Placing on the Market of Pyrotechnic Articles Regulations, 2010

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L.N. 156 of 2010

PRODUCT SAFETY ACT

(CAP. 427)

EXPLOSIVES ORDINANCE ACT

(CAP. 33)

Placing on the Market of Pyrotechnic Articles Regulations, 2010

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

Product Safety Act, the Minister of Finance, the Economy and

Investment, in consultation with the Minister for Justice and Home

Affairs, has made the following regulations:-

(1)

The title of these regulations is the Placing on the Title and scope.

Market of Pyrotechnic Articles Regulations, 2010.

(2) The scope of these regulations is to transpose Directive

2007/23/EC * of the European Parliament and of the Council of 23

May 2007 on the placing on the market of pyrotechnic articles.

(3) These regulations establish the essential safety

requirements which pyrotechnic articles must fulfil with a view to

their being placed on the market, and shall only apply to pyrotechnic

articles which are, or are intended to be, placed on the market.

These regulations shall enter into force on the 4 th Commencement.

[Regulations 6 and 8]

ESSENTIAL SAFETY REQUIREMENTS

(Based on Annex I of Directive 2007/23/EC)

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 batch of pyrotechnic articles 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 in

either the Maltese or English language;

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(i)

the ability of the pyrotechnic article, its wrapping or other

components to withstand deterioration under normal, foreseeable storage

conditions; and

(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

(a)

commercial blasting agents, except for black powder or flash

composition; or

(b)

military explosives.

5. The various groups of pyrotechnic articles must at least also comply

with the following requirements

(a)

fireworks

(i) the manufacturer must assign fireworks to different

categories according to regulations 3 (1) to (3), characterised by net

explosive content, safety distances, noise level or similar. The category

must be clearly indicated on the label.

For fireworks of category 1, the following conditions must be

-

the safety distance must be at least 1m. However, where

appropriate the safety distance may be less;

-

the maximum noise level must not exceed 120dB (A, imp),

or an equivalent noise level as measured by another appropriate method,

at the safety distance;

-

category 1 must not comprise bangers, banger batteries,

flash bangers and flash banger batteries;

-

throwdowns in category 1 must not contain more than

2.5mg silver fulminate.

For fireworks of category 2, the following conditions must be

-

the safety distance must be at least 8m. However, where

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appropriate the safety distance may be less;

-

the maximum noise level must not exceed 120dB (A, imp),

or an equivalent noise level as measured by another appropriate method,

at the safety distance.

For fireworks of category 3, the following conditions must be

met

-

the safety distance must be at least 15m. However, where

appropriate the safety distance may be less;

-

the maximum noise level must not exceed 120dB (A, imp)

or an equivalent noise level as measured by another appropriate method,

at the safety distance.

(ii) fireworks may only be constructed of materials which

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

(iii) the method of ignition must be clearly visible or must be

indicated by labelling or instructions;

(iv) fireworks must not move in an erratic and unforeseeable

manner;

(v) fireworks of category 1, 2 and 3 must be protected against

inadvertent ignition either by a protective cover, by the packaging, or by

the construction of the article. Fireworks of category 4 must be

protected against inadvertent ignition by methods specified by the

manufacturer.

(b)

other pyrotechnic articles

(i) pyrotechnic articles must be designed in such a way as to

minimise risk to health, property and the environment during normal

use;

(ii) the method of ignition must be clearly visible or must be

indicated by labelling or instructions;

(iii) 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;

(iv) where appropriate, the pyrotechnic article must function

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

(c)

ignition devices

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(i) ignition devices must be capable of being reliably initiated

and be of sufficient initiation capability under all normal, foreseeable

conditions of use;

(ii) ignition devices must be protected against electrostatic

discharge under normal, foreseeable conditions of storage and use;

(iii) electric igniters must be protected against electromagnetic

fields under normal, foreseeable conditions of storage and use;

(iv) the covering of fuses must be of adequate mechanical

strength and adequately protect the explosive filling when exposed to

normal, foreseeable mechanical stress;

(v) the parameters for the burning times of fuses must be

provided with the article;

(vi) the electrical characteristics (e.g. no-fire current,

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

(vii) 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.

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(1)

July 2010 for fireworks of categories 1, 2 and 3 and on the 4 th July

2013 for other pyrotechnic articles, for fireworks of category 4 and

for theatrical pyrotechnic articles.

(2) Maltese national authorisations granted before the relevant

date indicated in sub-regulation (1) shall continue to be valid in Malta

until their expiry date or up to ten years from the entry into force of

these regulations, whichever is the shorter.

(3) By way of derogation from sub-regulation (2), national

authorisations for pyrotechnic articles for vehicles granted before the

relevant date indicated in sub-regulation (1) shall continue to be valid

*

OJ No. L.154, 14-6-2007, p.1. Directive establishing the rules designed to achieve the

free movement of pyrotechnic articles in the internal market while, at the same time,

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.

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until their expiry.

[Regulation 7]

CONFORMITY ASSESSMENT PROCEDURES

(Based on Annex II of Directive 2007/23/EC)

MODULE B: EC type-examination

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

body ascertains and attests that a sample, representative of the production

envisaged, meets the relevant provisions of these regulations.

2. The application for EC type-examination must be lodged by the

manufacturer with the notified body of his choice. The application must 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 documents, as described in item 3.

The applicant must place at the disposal of the notified body a sample

representative of the production envisaged, hereinafter called "type". The notified

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

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

the requirements of these regulations to be assessed. They must, as far as is

relevant for such assessment, cover the design, manufacture and operation of the

article and contain where relevant for the assessment

(a)

a general type-description;

(b)

conceptual design and manufacturing drawings and diagrams of

components, sub-assemblies, circuits, etc;

(c)

descriptions and explanations necessary for the understanding of

the drawings and diagrams and the operation of the article;

(d)

a list of the harmonised standards referred to in regulation 8,

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

essential safety requirements of these regulations where the harmonised

standards referred to in regulation 8 have not been applied;

(e)

results of design calculations made, examinations carried out,

etc; and

(f)

test reports.

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4. The notified body must

(a)

examine the technical documents, verify that the type has been

manufactured in conformity with those documents and identify the elements

which have been designed in accordance with the relevant provisions of the

harmonised standards referred to in regulation 8 as well as the components

which have been designed without applying the relevant provisions of those

harmonised standards;

(b)

perform or have performed the appropriate examinations and

necessary tests to check whether, where the harmonised standards referred to

in regulation 8 have not been applied, the solutions adopted by the

manufacturer meet the essential safety requirements of these regulations;

(c)

perform or have performed the appropriate examinations and

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

the relevant harmonised standards, these have been applied; and

(d)

agree with the applicant the location where the examinations

and necessary tests are to be carried out.

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

notified body must issue an EC type-examination certificate to the applicant. The

certificate must contain the name and address of the manufacturer, the results of

the examination and the data necessary for the identification of the approved type.

A list of the relevant parts of the technical documents must be annexed to the

certificate and a copy thereof kept by the notified body.

Where the manufacturer is refused a type certificate, the notified body must

provide detailed reasons for such refusal.

Provision must be made for an appeals procedure.

6. The applicant must inform the notified body that holds the technical

documents concerning the EC type-examination certificate of all modifications to

the approved article which must receive additional approval where such changes

may affect the conformity with the essential requirements or the prescribed

conditions for use of the article. This additional approval must be given in the form

of an addition to the original EC type-examination certificate.

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

relevant information concerning EC type-examination certificates and additions

issued or withdrawn.

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

examination certificates and/or any additions thereto. The annexes to the

certificates must be kept at the disposal of the other notified bodies.

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9. The manufacturer must keep with the technical documents copies of EC

type-examination certificates and any additions thereto for a period of at least ten

years after the last date of manufacture of the article concerned. Where the

manufacturer is not established within the Community, the obligation to keep the

technical documents available is the responsibility of the person who places the

product on the market.

MODULE C: Conformity to type

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

manufacturer ensures and declares that the pyrotechnic articles concerned are in

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

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

must affix the CE marking to each pyrotechnic article and draw up a written

declaration of conformity.

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

manufacturing process ensures the conformity of the manufactured product with

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

safety requirements of these regulations.

3. The manufacturer must keep a copy of the declaration of conformity for

a period of at least ten years after the last date of manufacture of the article

concerned. Where the manufacturer is not established within the Community, the

obligation to keep the technical documents available is the responsibility of the

person who places the product on the market.

4. A notified body chosen by the manufacturer must perform or cause to

be performed examinations of the article at random intervals. A suitable sample of

the finished articles, taken on the spot by the notified body, must be examined and

appropriate tests, defined in the applicable harmonised standard referred to in

regulation 8 or equivalent, carried out to check the conformity of the article with

the requirements of these regulations. In the event of one or more samples of the

articles examined not conforming, the notified body must take appropriate

measures.

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

identification number of that body during the manufacturing process.

MODULE D: Production quality assurance

1. This module describes the procedure whereby a manufacturer who

satisfies the obligations set out in item 2 ensures and declares that the pyrotechnic

articles concerned are in conformity with the type as described in the EC type-

examination certificate and satisfy the requirements of these regulations. The

manufacturer must affix the CE marking to each article and draw up a written

declaration of conformity. The CE marking must be accompanied by the

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identification number of the notified body responsible for the monitoring referred

2. The manufacturer must operate an approved quality system for

production, final product inspection and testing as specified in item 3. He must be

subject to the monitoring referred to in item 4.

3. Quality system

(a)

the manufacturer must lodge an application for assessment of

his quality system with the notified body of his choice in relation to the

pyrotechnic articles concerned. The application must include

(i) all relevant information for the pyrotechnic article

category envisaged;

(ii) the documents concerning the quality system; and

(iii) the technical documents pertaining to the approved type

and a copy of the EC type-examination certificate.

(b)

the quality system must ensure the conformity of pyrotechnic

articles with the type as described in the EC type-examination certificate and

with the requirements of these regulations that apply to them.

All the elements, requirements and provisions adopted by the manufacturer

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

policies, procedures and instructions. The quality system documents must permit a

consistent interpretation of the quality programmes, plans, manuals and quality

They must contain in particular an adequate description of

(i) the quality objectives and the organisational structure,

responsibilities and powers of the management with regard to the

quality of the pyrotechnic articles;

(ii) the manufacturing, quality control and quality assurance

techniques, processes and systematic actions that will be used;

(iii) the examinations and tests that will be carried out before,

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

carried out;

(iv) the quality records, such as inspection reports and test

data, calibration data, and qualification reports of the personnel

concerned;

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(v) the means of monitoring the achievement of the required

quality of the pyrotechnic articles and the effective operation of the

quality system.

(c)

the notified body must assess the quality system to determine

whether it satisfies the requirements referred to in item 3(b). It must presume

conformity with those requirements in respect of quality systems that

implement the relevant harmonised standard. The auditing team must have at

least one member with experience of assessing the relevant product

technology. The assessment procedure must include an inspection visit to the

manufacturer’s premises.

A duly substantiated assessment decision must be notified to the

manufacturer. It must contain the results of the examination.

(d)

the manufacturer must undertake to fulfil the obligations arising

out of the quality system as approved and maintain it at an adequate and

efficient level.

The manufacturer must keep the notified body that has approved the

quality system informed of any proposed change to the quality system.

The notified body must assess the changes proposed and decide whether

the altered quality system will still satisfy the requirements referred to in

item 3(b) or whether reassessment is required.

A duly substantiated assessment decision must be notified to the

manufacturer. It must contain the results of the examination.

4. Monitoring under the responsibility of the notified body

(a)

the purpose of monitoring is to make sure that the manufacturer

duly fulfils the obligations arising out of the approved quality system;

(b)

the manufacturer must allow the notified body access for

inspection purposes to the manufacturing, inspection, testing and storage

premises and provide it with all necessary information, in particular

(i)

the quality system documents; and

(ii) the quality records, such as inspection reports and test

data, calibration data, and qualification reports of the personnel

concerned;

(c)

the notified body must periodically carry out audits to make sure

that the manufacturer maintains and applies the quality system and provide

an audit report to the manufacturer;

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(d)

additionally the notified body may pay unannounced visits to

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

carry out tests or have them carried out to verify that the quality system is

functioning correctly. The notified body must provide the manufacturer with

a visit report and, if a test has taken place, with a test report.

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

date of manufacture of the article, keep at the disposal of the national authorities

(a)

the documents referred to in item 3(a)(ii);

(b)

documents relating to the updating referred to in second

subparagraph of item 3(d); and

(c)

the decisions and reports of the notified body referred to in the

fourth subparagraph of item 3(d), and in items 4(c) and (d).

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

information concerning quality system approvals issued or withdrawn.

MODULE E: Product quality assurance

1. This module describes the procedure whereby a manufacturer who

satisfies the obligations set out in item 2 ensures and declares that the pyrotechnic

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

certificate. The manufacturer must affix the CE marking to each article and draw

up a written declaration of conformity. The CE marking must be accompanied by

the identification number of the notified body responsible for the monitoring

referred to in item 4.

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

pyrotechnic article inspection and testing as specified in item 3. He must be subject

to the monitoring referred to in item 4.

3. Quality system

(a)

the manufacturer must lodge an application with the notified

body of his choice for the assessment of the quality system in relation to his

pyrotechnic articles. The application must include

(ii) all relevant information for the pyrotechnic category

envisaged;

(ii) the quality system documents; and

(iii) the technical documents pertaining to the approved type

and a copy of the EC type-examination certificate.

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(b)

under the quality system, each pyrotechnic article must be

examined and appropriate tests, as defined in the relevant harmonised

standard(s) referred to in regulation 8 or equivalent, carried out in order to

verify the conformity of the article with the relevant requirements of these

regulations.

All the elements, requirements and provisions adopted by the

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

form of written policies, procedures and instructions. The quality system

documents must permit a consistent interpretation of the quality

programmes, plans, manuals and quality records.

They must in particular contain an adequate description of

(i) the quality objectives and the organisational structure,

responsibilities and powers of the management with regard to product

quality;

(ii) the examination and tests that will be carried out after

manufacture;

(iii) the means of monitoring the effective operation of the

quality system; and

(iv) quality records, such as inspection reports and test data,

calibration data, and qualification reports of the personnel concerned.

(c)

the notified body must assess the quality system to determine

whether it satisfies the requirements referred to in item 3(b). It must presume

conformity with these requirements in respect of quality systems that

implement the relevant harmonised standards.

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

assessing the relevant product technology. The assessment procedure must

include an inspection visit to the manufacturer’s premises.

A duly substantiated assessment decision must be notified to the

manufacturer. It must contain the results of the examination.

(d)

the manufacturer must undertake to fulfil the obligations arising

out of the quality system as approved and maintain it at an adequate and

efficient level.

The manufacturer must keep the notified body which has approved the

quality system informed of any proposed change to the quality system.

The notified body must assess the changes proposed and decide whether

the altered quality system will still satisfy the requirements referred to in

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item 3(b) or whether a reassessment is required.

A duly substantiated assessment decision must be notified to the

manufacturer. It must contain the results of the examination.

4. Monitoring under the responsibility of the notified body

(a)

the purpose of monitoring is to make sure that the manufacturer

duly fulfils the obligations arising out of the approved quality system;

(b)

the manufacturer must allow the notified body access for

inspection purposes to the manufacturing, inspection, testing and storage

premises and provide it with all necessary information, in particular

(i)

the quality system documents;

(ii) the technical documents;

(iii) the quality records, such as inspection reports and test

data, calibration data and qualification reports of the personnel

concerned.

(c)

the notified body must periodically carry out audits to ensure

that the manufacturer maintains and applies the quality system and must

provide an audit report to the manufacturer;

(d)

additionally, the notified body may pay unannounced visits to

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

carry out tests or have them carried out to verify that the quality system is

functioning correctly. The notified body must provide the manufacturer with

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

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

date of manufacture of the article, keep at the disposal of the national authorities

(a)

the documents referred to in item 3(a)(ii);

(b)

documents relating to the updating referred to in the second sub-

paragraph of item 3(d);

(c)

the decisions and reports of the notified body referred to in the

fourth sub-paragraph of item 3(d), and in items 4(c) and (d).

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

relevant information concerning quality system approvals issued or withdrawn.

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MODULE G: Unit verification

1. This module describes the procedure whereby the manufacturer ensures

and declares that the pyrotechnic article which has been issued with the certificate

referred to in item 2 conforms with the relevant requirements of these regulations.

The manufacturer must affix the CE marking to the article and draw up a

declaration of conformity.

2. The notified body must examine the pyrotechnic article and carry out

the appropriate tests as set out in the relevant harmonised standard(s) referred to in

regulation 8, or equivalent tests, to ensure the conformity of the article with the

relevant requirements of these regulations.

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

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

operation of the pyrotechnic article to be understood

(a)

a general description of the type;

(b)

conceptual design and manufacturing drawings and schemes of

components, sub-assemblies and circuits;

(c)

the descriptions and explanations necessary for the

understanding of the conceptual design and manufacturing drawings, the

schemes of components, sub-assemblies and circuits and the operation of the

pyrotechnic article;

(d)

a list of the harmonised standards referred to in regulation 8,

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

essential safety requirements of these regulations where the harmonised

standards referred to in regulation 8 have not been applied;

(e)

results of design calculations made and examinations carried

out;

(f)

test reports.

MODULE H: Full quality assurance

1. This module describes the procedure whereby the manufacturer who

satisfies the obligations set out in item 2 ensures and declares that the articles

concerned meet the requirements of these regulations. The manufacturer or his

importer must affix the CE marking to each article and draw up a written

declaration of conformity. The CE marking must be accompanied by the

identification number of the notified body responsible for the monitoring referred

to in item 4.

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2. The manufacturer must operate an approved quality system for the

design, production, final product inspection and testing as specified in item 3 and

must be subject to the monitoring referred to in item 4.

3. Quality system

(a)

the manufacturer must lodge an application for assessment of

his quality system with a notified body. The application must include

(i) all relevant information for the pyrotechnic article

category envisaged; and

(ii) the documents concerning the quality system.

(b)

the quality system must ensure the conformity of the article with

the requirements of these regulations.

All the elements, requirements and provisions adopted by the manufacturer

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

policies, procedures and instructions. The quality system documents must permit a

consistent interpretation of the quality programmes, plans, manuals and quality

They must contain in particular an adequate description of

(i) the quality objectives and the organisational structure,

responsibilities and powers of the management with regard to product

design and quality;

(ii) technical construction specifications including the

standards applicable and, if the standards referred to in regulation 8

have not been fully applied, the means of ensuring that the relevant

basic requirements of these regulations have been met;

(iii) techniques to control and assess the development results,

processes and systematic actions that will be used to develop products

belonging to the product category in question;

(iv) the manufacturing, quality control and quality assurance

techniques and the processes and systematic actions applied;

(v) the examinations and tests that will be carried out before,

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

carried out;

(vi) the quality records, such as inspection reports and test

data, calibration data, and qualification reports of the personnel

concerned;

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(vii) the means of monitoring the achievement of the required

design and quality of the product and the effective operation of the

quality system.

(c)

the notified body must assess the quality system to determine

whether it satisfies the requirements referred to in item 3(b). It must presume

conformity with those requirements in respect of quality systems that

implement the relevant harmonised standard.

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

assessing the relevant product technology. The assessment procedure shall

include an inspection visit to the manufacturer’s premises.

A duly substantiated assessment decision must be notified to the

manufacturer. It must contain the results of the examination.

(d)

the manufacturer must undertake to fulfil the obligations arising

out of the quality system as approved and maintain it at an adequate and

efficient level.

The manufacturer must keep the notified body that has approved the

quality system constantly informed of any proposed update of the quality

system.

The notified body must assess the changes proposed and decide whether

the altered quality system will still satisfy the requirements referred to in

item 3(b) or whether reassessment is required.

A duly substantiated assessment decision must be notified to the

manufacturer. It must contain the results of the examination.

4. EC monitoring under the responsibility of the notified body

(a)

the purpose of EC monitoring is to make sure that the

manufacturer duly fulfils the obligations arising out of the approved quality

system;

(b)

the manufacturer must allow the notified body access for

inspection purposes to the manufacturing, inspection, testing and storage

premises and provide it with all necessary information, in particular

(i)

the quality system documents;

(ii) the quality records required under the quality system for

the development field such as the results of analyses, calculations and

tests;

(iii) the quality records required under the quality system for

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the manufacturing field such as inspection reports and test data,

calibration data, and qualification reports of the personnel concerned;

(c)

the notified body must periodically carry out audits to make sure

that the manufacturer maintains and applies the quality system and provide

an audit report to the manufacturer;

(d)

additionally, the notified body may pay unannounced visits to

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

carry out tests or have them carried out to verify that the quality system is

functioning correctly. The notified body must provide the manufacturer with

a visit report and, if a test has taken place, with a test report.

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

date of manufacture of the article, keep at the disposal of the national authorities

(a)

the documents referred to in item 3(a)(ii);

(b)

documents relating to the updating referred to in second sub-

paragraph of item 3(d); and

(c)

the decisions and reports of the notified body referred to in the

fourth subparagraph of item 3(d), and in items 4(c) and (d).

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

information concerning quality system approvals issued or withdrawn.

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These regulations shall not apply to

(a)

pyrotechnic articles intended for non-commercial

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

Civil Protection Department;

(b)

explosives falling within the scope of the Civil

Explosives Regulations, transposing Directive 93/15/EEC * ;

(c)

equipment falling within the scope of the

Conformity Assessment of Marine Equipment Regulations,

transposing Directive 96/98/EC ** ;

(d)

pyrotechnic articles intended for use in the

aerospace industry;

(e)

percussion caps intended specifically for toys

falling within the scope of Safety of Toys Regulations,

transposing Directive 88/378/EEC *** ; and

(f)

ammunition, meaning projectiles and propelling

charges and blank ammunition used in portable firearms, other

guns and artillery, as defined under the Arms Act and its

regulations.

[Regulations 4 and 9]

MINIMUM CRITERIA TO BE TAKEN INTO ACCOUNT BY MEMBER STATES

FOR THE BODIES RESPONSIBLE FOR CONFORMITY ASSESSMENTS

(Based on Annex III of Directive 2007/23/EC)

1. Notified bodies shall be subject to the Method for Designating

Conformity Assessment Bodies Regulations and they shall also fulfil the criteria

set out below.

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

verification tests must not be the designer, manufacturer, supplier, installer or

importer of pyrotechnic articles which they inspect, nor the authorised

representative of any of these parties. They must not become involved either

directly or as authorised representative in the design, construction, marketing,

maintenance or importation of such articles. This does not preclude the possibility

of exchanges of technical information between the manufacturer and the body.

3. The body and its staff must carry out the verification tests with the

highest degree of professional integrity and technical competence and must be free

from all pressures and inducements, particularly financial, which might influence

their judgment or the results of the inspection, especially from persons or groups of

persons with an interest in the result of verification.

4. The body must have at its disposal the necessary staff and possess the

necessary facilities to enable it to perform properly the administrative and

technical tasks connected with verification; it must also have access to the

equipment required for special verification.

5. The staff responsible for inspection must have

(a)

sound technical and professional training;

(b)

satisfactory knowledge of the requirements of the tests they

carry out and adequate experience of such tests;

(c)

the ability to draw up the certificates, records and reports

required to authenticate the performance of the tests.

6. The impartiality of inspection staff must be guaranteed. Their

remuneration must not depend on the number of tests carried out or on the results

of such tests.

7. The body must take out civil liability insurance unless its liability is

assumed by the State under Maltese law or the Regulatory Affairs Directorate and

Market Surveillance Directorate themselves carry out the inspections directly.

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8. The staff of the body must observe professional secrecy with regard to

all information gained in carrying out its tasks (except vis-à-vis the Regulatory

Affairs Directorate or other competent administrative authorities of the State in

which their activities are carried out) under these regulations or any provision of

national law giving effect to it.

In these regulations, unless the context otherwise

requires:–

"Community" means the European Community;

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

chain who makes a pyrotechnic article available on the market in the

course of his business, whether this is acquired from a local or foreign

manufacturer or importer, or brought into Malta by any means

whatsoever;

"Firework" means

a

pyrotechnic

article

intended

for

entertainment purposes;

OJ No. L.121, 15-05-1993, p.20-36. Council Directive 93/15/EEC of 5 April 1993 on

the harmonization of the provisions relating to the placing on the market and

supervision of explosives for civil uses.

** OJ No. L.46, 17-02-1997, p.25-56. Council Directive 96/98/EC of 20 December 1996

on marine equipment.

***OJ No. L.187, 16-07-1988, p.1. Council Directive of 3 May 1988on the approximation

of the laws of the Member States concerning the safety of toys.

VER|JONI ELETTRONIKA

"Harmonised standard" means a European standard adopted by

a European standardisation body under a mandate from the

Commission in conformity with the procedures laid down in the

Notification Procedure Regulations, and with which compliance is S.L. 419.06.

not compulsory;

"Importer" means any natural or legal person established in the

Community who makes a pyrotechnic article originating from a third

country available on the Community market for the first time in the

course of his business;

"Manufacturer" means a natural or legal person who designs or

manufactures, or causes to be designed or manufactured, a

pyrotechnic article with a view to placing it on the market under his

own name or trademark;

"Market Surveillance Directorate" means the Market

Surveillance Directorate of the Malta Standards Authority as

described in the Establishment of Directorates of the Malta Standards S.L. 419.03.

Authority Order;

"Minister" means the Minister responsible for the Police;

"Notified Body" means a body notified to the Commission and

to the Member States of the Community, assessed according to the

criteria laid down in the Third Schedule and appointed to carry out

the relevant procedures referred to in these regulations. The names of

such bodies are published in the Official Journal of the European

Union;

"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 on the

Community market of an individual product, with a view to its

distribution and/or use, whether for payment or free of charge.

Fireworks shall not be considered as having been placed on the

market if they are manufactured 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;

"Pyrotechnic article" means any article containing explosive

substances or an explosive mixture of substances designed to produce

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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;

"Regulatory Affairs Directorate" means the Regulatory Affairs

Directorate of the Malta Standards Authority as described in the

Establishment of Directorates of the Malta Standards Authority

Order; and

"Theatrical pyrotechnic articles" means pyrotechnic articles

designed for indoor or outdoor stage use, including film and

television productions or similar use.

CONFORMITY MARKING

(Based on Annex IV of Directive 2007/23/EC)

The CE conformity marking must consist of the initials "CE" taking the

following form

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

graduated drawing must be respected.

Mitbug] fl-Istamperija tal-Gvern fuq karta ri`iklata - Printed at the Government Printing Press on recycled paper

€2.80

(1)

Pyrotechnic articles to be placed on the market

shall be categorised by the manufacturer in accordance with the

provisions of sub-regulation (2). Categorisation shall be based on

type of use, purpose and level of hazard, including noise level

Provided, that the notified bodies referred to in regulation

9(1) and (2) shall confirm the categorisation as part of the conformity

assessment procedures in accordance with regulation 7(1).

(2) Categorisation shall be as follows

(a)

fireworks

(i) category 1: 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 2: fireworks which present a low

hazard and low noise level and which are intended for

outdoor use in confined areas;

(iii) category 3: 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; and

(iv) category 4: fireworks which present a high

hazard, which are intended for use only by persons with

specialist knowledge (commonly known as fireworks for

professional use) and whose noise level is not harmful to

human health.

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(b)

theatrical pyrotechnic articles

(i) category T1: pyrotechnic articles for stage

use which present a low hazard; and

(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; and

(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 Regulatory

Affairs Directorate of the procedures whereby persons with specialist

knowledge are identified and authorised. The Regulatory Affairs

Directorate shall then inform the European Commission of such

Pyrotechnic articles shall not be sold or otherwise Sale and

availability of

made available to consumers below the following age limits

pyrotechnic

articles.

(a)

fireworks

(i)

category 1: 12 years; and

(ii) category 2, 3 and 4: 18 years.

(b)

other pyrotechnic

articles

and

theatrical

pyrotechnic articles

(i)

category P1, P2, T1 and T2: 18 years.

(2) Manufacturers, importers and distributors shall not sell or

otherwise make available the following pyrotechnic articles except to

persons with specialist knowledge

(a)

fireworks of category 2, 3 and 4; and

(b)

pyrotechnic articles of categories P1 and P2 and

theatrical pyrotechnic articles of categories T1 and T2.

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(1)

Pyrotechnic articles shall be placed on the Maltese

market only if they satisfy the requirements of these regulations, bear

the CE marking and comply with the obligations relating to the

conformity assessment.

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

satisfies 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 by the manufacturer, where

such manufacturer is established within the Community, or by the

importer. 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.

(1)

Manufacturers shall ensure that pyrotechnic

articles placed on the market comply with the essential safety

requirements set out in the First Schedule. Manufacturers of

pyrotechnic articles intended to be placed on the market shall

(a)

submit the pyrotechnic article to a notified body as

referred to in regulations 11(1) to (4) which shall perform a

conformity assessment in accordance with regulation 9(1); and

(b)

affix a CE marking to, and label the pyrotechnic

article in accordance with regulations 9(2) to (4), and

regulations 12 or 13.

(2) If the manufacturer is not established in the Community,

the importer of the pyrotechnic articles shall ensure that the

manufacturer has fulfilled his obligations under these regulations or

assume liability for these obligations himself. The importer may be

held liable by authorities and bodies in the Community with regard to

those obligations.

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(3) Distributors shall act with due care in accordance with

applicable Community law. In particular, they shall verify that the

pyrotechnic article bears the required conformity marking(s) and is

accompanied by the required documents.

(1)

For the assessment of conformity of pyrotechnic Conformity

articles, the manufacturer shall follow one of the following Assessment

Procedures and

procedures

obligation to

affix CE

marking.

(a)

the EC type-examination (Module B) procedure

referred to in the Second Schedule and at the choice of the

manufacturer, either

(i) the conformity to type (Module C) procedure

referred to in the Second Schedule; or

(ii) the production quality assurance (Module D)

procedure referred to in the Second Schedule; or

(iii) the product quality assurance (Module E)

procedure referred to in the Second Schedule;

(b)

the unit verification (Module G) procedure referred

to in the Second Schedule; or

(c)

the full product quality assurance procedure

(Module H) referred to in the Second Schedule, in so far as it

concerns fireworks of category 4.

(2) After having successfully completed the conformity

assessment in accordance with sub-regulation (1), manufacturers

shall visibly, legibly and indelibly affix the CE marking to the

pyrotechnic articles themselves or, if this is not possible, to an

identification plate attached thereto or to the packaging. The

identification plate must be so designed as to make its reuse

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

accordance with Decision 93/465/EEC * .

(3) No marking or inscription which may confuse third

persons as to the meaning and form of the CE marking may be affixed

to pyrotechnic articles. Any other marking may be affixed to

pyrotechnic articles provided the visibility and legibility of the CE

marking is not impaired.

*

OJ No. L 220, 30-08-1993, p. 23–39. Council Decision of 22 July 1993 concerning the

modules for the various phases of the conformity assessment procedures and the rules

for the affixing and use of the CE conformity marking, which are intended to be used in

the technical harmonization directives.

VER|JONI ELETTRONIKA

(4) Where pyrotechnic articles are subject to other Community

or Maltese legislation which covers other aspects of, and prescribes

the affixing of, the CE marking, this marking shall indicate that those

articles are also presumed to conform to the provisions of the other

legislation which applies to them.

(1)

Harmonised standards published in the Official

Journal of the European Union shall be acknowledged and adopted by

the Regulatory Affairs Directorate and published in the Gazette.

Conformity to the essential safety requirements set out in the First

Schedule shall be presumed for pyrotechnic articles falling within the

scope of these regulations which comply with the relevant national

standards transposing the harmonised standards published in the

Official Journal of the European Union.

(2) When it is considered that the harmonised standards

referred to in sub-regulation (1) do not fully satisfy the essential

safety requirements set out in the First Schedule, the Regulatory

Affairs Directorate shall refer the matter to the Standing Committee

set up by Directive 98/34/EC, giving its reasons.

(1)

The Regulatory Affairs Directorate shall apply the

minimum criteria set out in the Third Schedule for the assessment of

bodies of which the Commission is to be notified. Bodies which meet

the assessment criteria laid down by the harmonised standards

relevant for notified bodies shall be presumed to satisfy the relevant

minimum criteria.

(2) The Regulatory Affairs Directorate shall withdraw the

notification if it discovers that the body no longer meets the minimum

criteria referred to in sub-regulation (1). It shall immediately inform

the other Member States and the Commission thereof.

(3) If the notification of a body is withdrawn, the attestations

of conformity and the related documents provided by the body in

question shall remain valid unless it is established that there is an

imminent and direct risk to health and safety.

(4) The Regulatory Affairs Directorate shall inform the

Commission and the other Member States of the bodies which it has

appointed to carry out the conformity assessment procedures referred

to in sub-regulation (1), together with the specific tasks which these

bodies have been appointed to carry out and the identification

numbers assigned to them by the Commission.

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(1)

Manufacturers or importers shall ensure that Labelling of

pyrotechnic articles other than pyrotechnic articles for vehicles are articles

than pyrotechnic

properly labelled visibly, legibly and indelibly in, at least, the Maltese articles

vehicles.

or English language.

(2) The labelling of pyrotechnic articles as are referred to in

sub-regulation (1) shall at least include the name and address of the

manufacturer or, where the manufacturer is not established in the

Community, the name of the manufacturer and the name and address

of the importer, the name and type of the article, the minimum age

limits as indicated in regulations 4(1) and (2), the relevant category

and instructions for use, the year of production for fireworks of

category 3 and 4 and, a minimum safety distance. The labelling shall

include the net equivalent quantity (NEQ) of active explosive

material.

(3) In addition, fireworks shall display the following minimum

information

(a)

category 1: where appropriate: "for outdoor use

only" and a minimum safety distance;

(b)

category 2: "for outdoor use only" and minimum

safety distance(s);

(c)

category 3: "for outdoor use only" and minimum

safety distance(s); and

(d)

category 4: "for use only by persons with specialist

knowledge" and minimum safety distance(s).

(4) In addition, theatrical pyrotechnic articles shall display the

following minimum information

(a)

category T1: where appropriate: "for outdoor use

only" and a minimum safety distance; and

(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) to (4),

the information shall be provided on the smallest piece of packaging.

(6) The provisions of this regulation shall not apply to

pyrotechnic articles shown at trade fairs, exhibitions and

demonstrations for the marketing of pyrotechnic articles, as referred

to in regulation 5(3), or manufactured for the purpose of research,

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development and testing, as referred to in regulation 5(4).

(1)

The labelling of pyrotechnic articles for vehicles

shall include the name of the manufacturer or, where the

manufacturer is not established in the Community, the name of the

importer, the name and type of the article and the safety instructions.

(2) If the article does not provide sufficient space for the

labelling requirements referred to in sub-regulation (1), the

information shall be provided on the packaging.

(3) The labelling referred to in sub-regulations (1) and (2) shall

be in at least the Maltese or English language.

(4) A safety data sheet compiled in accordance with Annex II

to Regulation (EC) 1907/2006 * shall be supplied to professional users

in the language requested by them. The safety data sheet may be

supplied on paper or electronically, provided that the addressee has

the necessary means of accessing it.

(1)

All appropriate measures shall be taken by the

Market Surveillance Directorate, upon consultation with the

Commissioner of Police, 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.

(2) Regular inspections of pyrotechnic articles shall be carried

out by the Market Surveillance Directorate on entry in Malta and at

storage and manufacturing sites

Provided that in the case of inspections at storage and

manufacturing sites, the Market Surveillance Directorate shall be

accompanied by the Police.

(3) The Market Surveillance Directorate shall, upon

consultation with the competent authorities, take all appropriate

measures to ensure that when pyrotechnic articles are transferred

within the Community, the safety and public security and protection

requirements of these regulations are met.

*

OJ No. L 396, 30-12-2006, p. 1–849. Regulation (EC) No 1907/2006 of the European

Parliament and of the Council of 18 December 2006 concerning the Registration,

Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a

European Chemicals Agency, amending Directive 1999/45/EC and repealing Council

Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as

Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC,

93/105/EC and 2000/21/EC.

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(4) The Market Surveillance Directorate shall organise and

perform appropriate surveillance of products placed on the market

taking due account of the presumption of the conformity of products

bearing a CE marking.

(5) The Director of Market Surveillance shall set an annual

plan for market surveillance activities under these regulations.

(6) Where it is ascertained that a pyrotechnic article, bearing a

CE marking, accompanied by the EC declaration of conformity and

used in accordance with its intended purpose, is liable to endanger the

health and safety of persons, the Market Surveillance Directorate

shall take all appropriate provisional measures to withdraw that

article from the market, to prohibit its being placed on the market or

to restrict its free movement. The Regulatory Affairs Directorate shall

inform the Commission and the other Member States thereof.

(7) Where the Commissioner of Police, or the Market

Surveillance Directorate, has sufficient reasons to believe that a

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

persons in Malta or the Community, the Regulatory Affairs

Directorate shall inform the Commission and the Member States

thereof and shall perform an appropriate evaluation. It shall inform

the Commission and other Member States of the background for and

the results of the evaluation.

(8) Where the Commissioner of Police, upon consultation with

the Market Surveillance Directorate and the Regulatory Affairs

Directorate, disagrees with the provisional measures taken by another

Member State pursuant to sub-regulation (6), the Regulatory Affairs

Directorate shall inform the Commission and await its evaluation of

the measures.

(9) Where a pyrotechnic article does not conform but bears a

CE marking, the Market Surveillance Directorate shall take

appropriate action against whoever affixed the marking and the

Regulatory Affairs Directorate shall inform the Commission thereof.

(10) Any measure taken pursuant to these regulations

(a)

to prohibit or restrict the placing on the market of a

product; or

(b)

to withdraw a product from the market,

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shall state the exact grounds on which it is based. Such measures

shall be notified without delay to the party concerned, who shall at

the same time be informed of the remedies available to him under the

Product Safety Act and the Ordinance, and of the time limits to which

such remedies are subject. In such case, the party concerned shall

have an opportunity to put forward his views in advance, unless such

consultation is not possible because of the urgency of the measure to

be taken, as justified in particular by public health or safety

requirements.

(11)

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

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

laid down in that law shall apply.

(2) The necessary measures allowing the detainment of

consignments of pyrotechnic articles that fail to comply with the

provisions of these regulations shall be those under the Product

Safety Act and the Ordinance.

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