# EUR-Lex - 52011PC0771 - EN

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# 52011PC0771

**Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the harmonisation of the laws of the Member States relating to the  making available  on the market and supervision of explosives for civil uses /* COM/2011/0771 final - 2011/0349 (COD) */**

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EXPLANATORY MEMORANDUM

1.
context of the proposal

General context, reasons for and
objectives of this proposal

This proposal is presented in the framework
of the implementation of the “goods package” adopted in 2008. It is part
of a package of proposals aligning ten product directives to Decision No
768/2008/EC establishing
a common framework for the marketing of products.

Union (EU) harmonisation legislation
ensuring the free movement of products has contributed considerably to the
completion and operation of the Single Market. It is based on a high level of
protection and provides economic operators with the means to demonstrate
conformity, thus ensuring free movement through trust in the products.

Council Directive 93/15/EEC on the
harmonization of the provisions relating to the placing on the market and
supervision of explosives for civil uses is an example of that Union
harmonisation legislation, ensuring the free movement of explosives. It sets
out essential safety requirements that explosives must comply with in order to
be made available on the EU market. Manufacturers must demonstrate that an
explosive has been designed and manufactured in compliance with the essential
safety requirements and affix the CE marking.

Experience with the implementation of Union
harmonisation legislation has shown – on a cross-sector scale – certain
weaknesses and inconsistencies in the implementation and enforcement of this
legislation, leading to:

–
the presence of non-compliant or dangerous
products on the market and consequently a certain lack of trust in CE marking;

–
competitive disadvantages for economic operators
complying with the legislation as opposed to those circumventing the rules;

–
unequal treatment in the case of non-compliant
products and distortion of competition amongst economic operators due to
different enforcement practices;

–
differing practices in the designation of
conformity assessment bodies by national authorities;

–
problems with the quality of certain notified
bodies.

Furthermore the regulatory environment has
become more and more complex, as frequently several pieces of legislation apply
simultaneously to one and the same product. Inconsistencies in these pieces of
legislation make it increasingly difficult for economic operators and
authorities to correctly interpret and apply that legislation.

To remedy these horizontal shortcomings in
Union harmonisation legislation observed across several industrial sectors, the
“New Legislative Framework” was adopted in 2008 as part of the goods
package. Its objective is to strengthen and
complete the existing rules and to improve practical aspects of their
application and enforcement. The New Legislative Framework (NLF) consists of
two complementary instruments, Regulation (EC) No 765/2008 on
accreditation and market surveillance and Decision No 768/2008
establishing a common framework for the marketing of products.

The NLF Regulation has introduced rules on
accreditation (a tool for the evaluation of competence of conformity assessment
bodies) and requirements for the organisation and performance of market
surveillance and controls of products from third countries. Since 1 January
2010 these rules apply directly in all Member States.

The NLF Decision sets out a common
framework for EU product harmonisation legislation. This framework consists of
the provisions which are commonly used in EU product legislation (e.g.
definitions, obligations of economic operators, notified bodies, safeguard
mechanisms, etc.). These common provisions have been reinforced to ensure that the
directives can be applied and enforced more effectively in practice. New
elements, such as obligations on importers, have been introduced, which are
crucial for improving the safety of products on the market.

The provisions of the NLF Decision and those
of the NLF Regulation are complementary and closely interlinked. The NLF
Decision contains the corresponding obligations for economic operators and
notified bodies allowing market surveillance authorities and authorities
responsible for notified bodies to properly perform the tasks imposed on them
by the NLF Regulation and to ensure an effective and consistent enforcement of
EU product legislation.

However, unlike the NLF Regulation, the
provisions of the NLF Decision are not directly applicable. To ensure that all
economic sectors subject to Union harmonisation legislation benefit from the
improvements of the NLF, the provisions of the NLF Decision need to be
integrated into the existing product legislation.

A survey after the adoption of the goods
package in 2008 showed that a majority of Union harmonisation legislation on
products was due to be revised within the following 3 years, not only to
address the problems observed throughout all sectors but also for
sector-specific reasons. Any such revision would automatically include an
alignment of the legislation concerned to the NLF Decision since Parliament,
Council and Commission have committed themselves to use its provisions as much
as possible in future legislation on products in order to further the utmost
coherence of the regulatory framework.

For a number of other Union harmonisation
directives, including Council Directive 93/15/EEC on the harmonization of the
provisions relating to the placing on the market and supervision of explosives
for civil uses no revision for sector-specific problems had been envisaged
within this timeframe. To ensure that the problems in relation to
non-compliance and notified bodies are nevertheless addressed in these sectors,
and for the sake of consistency of the overall regulatory environment on
products, it was decided to align these directives within a package to the
provisions of the NLF Decision.

Consistency with other policies and
objectives of the Union

This initiative is in
line with the Single Market Act[1],
which has stressed the need to restore consumer confidence in the quality of
products on the market and the importance of reinforcing market surveillance.

Furthermore it supports
the Commission’s policy on Better Regulation and simplification of the
regulatory environment.

2.
consultation of interested parties and impact
assessment

Consultation of interested parties

The alignment of Council Directive
93/15/EEC on the harmonization of the provisions relating to the placing on the
market and supervision of explosives for civil uses to the NLF Decision has
been discussed with the national experts responsible for the implementation of
this Directive in the explosives working group, the Forum of notified bodies as
well as in bilateral meetings with industry associations.

From June to October 2010 a public
consultation was organised that comprised all the sectors involved in this
initiative. It consisted of four targeted questionnaires for economic
operators, authorities, notified bodies and users and the Commission services
received 300 replies. The results are published at:

http://ec.europa.eu/enterprise/policies/single-market-goods/regulatory-policies-common-rules-for-products/new-legislative-framework/index_en.htm

In addition to the general consultation a
specific SME consultation was carried out. 603 SMEs were consulted through the
Enterprise Europe Network in May/June 2010. The results are available at http://ec.europa.eu/enterprise/policies/single-market-goods/files/new-legislative-framework/smes_statistics_en.pdf

The consultation process revealed
widespread support for the initiative. There is unanimity on the need to
improve market surveillance and the system for assessing and monitoring
Notified Bodies. Authorities fully support the exercise because it will
strengthen the existing system and improve cooperation at EU level. Industry
expects a more level playing field resulting from more effective actions
against products that do not comply with the legislation, as well as a simplification
effect from the alignment of legislation. Certain concerns were expressed on
some obligations which are, however, indispensable for increasing the
efficiency of market surveillance. These measures will not entail significant
costs for industry, and the benefits resulting from improved market
surveillance should by far outweigh the costs.

Collection and use of expertise

The impact assessment for this
implementation package has largely built on the impact assessment carried out
for the New Legislative Framework. In addition to the expertise collected and
analysed in that context, further consultation of sector-specific experts and
interest groups, as well as horizontal experts active in the area of technical
harmonisation, conformity assessment, accreditation and market surveillance,
has taken place.

Impact assessment

Based on the information collected, the
Commission carried out an impact assessment which examined and compared three
options.

Option 1 – No changes to the current
situation

This option proposes no changes to the
current directive and relies exclusively on certain improvements that can be
expected from the NLF Regulation.

Option 2 – Alignment to the NLF Decision
by non-legislative measures

Option 2 considers the possibility of
encouraging a voluntary alignment to the provisions set out in the NLF Decision
by, e.g., presenting them as best practices in guidance documents.

Option 3 – Alignment to NLF Decision by
legislative measures

This option consists in integrating the
provisions of the NLF Decision into the existing directives.

Option 3 was
found to be the preferred option because:

–
it will improve the competitiveness of companies
and notified bodies taking their obligations seriously, as opposed to those
cheating on the system;

–
it will improve the functioning of the internal
market by ensuring equal treatment of all economic operators, notably importers
and distributors, as well as notified bodies;

–
it does not entail significant costs for
economic operators and notified bodies; for those who are already acting
responsibly, no extra costs or only negligible costs are expected;

–
it is considered more effective than option 2:
due to the lack of enforceability of option 2 it is questionable that the
positive impacts would materialise under that option;

–
options 1 and 2 do not provide answers to the
problem of inconsistencies in the regulatory framework and therefore have no
positive impact on the simplification of the regulatory environment.

3.
Main elements of the proposal

Horizontal definitions

The proposal
introduces harmonised definitions of terms which are commonly used throughout
Union harmonisation legislation and should therefore be given a consistent
meaning throughout that legislation.

3.1.
Obligations of economic operators and
traceability requirements

The proposal clarifies the obligations of
manufacturers and authorised representatives and introduces obligations for
importers and distributors. Importers must verify that the manufacturer has
carried out the applicable conformity assessment procedure and has drawn up a
technical documentation. They must also make sure with the manufacturer that
this technical documentation can be made available to authorities upon request.
Furthermore importers must verify that the explosives are correctly marked and
accompanied by the required instructions and safety information. They must keep
a copy of the Declaration of conformity and ensure that the explosives bear a
unique identification in accordance with Directive 2008/43/EC. Distributors
must verify that the explosive bears the CE marking, the unique identification
and that it is accompanied by the required documentation and instructions.

Importers and distributors must cooperate
with market surveillance authorities and take appropriate actions when they have
supplied non-compliant explosives.

3.2.
Harmonised standards

Compliance with harmonised standards
provides a presumption of conformity with the essential requirements. On 1 June
2011 the Commission adopted a proposal for a Regulation on European
Standardisation[2]
that sets out a horizontal legal framework for European standardisation. The
proposal for the Regulation contains inter alia provisions on standardisation
requests from the Commission to the European Standardisation Organisations, on
the procedure for objections to harmonised standards and on stakeholder
participation in the standardisation process. Consequently the provisions of Directive
93/15/EEC which cover the same aspects have been deleted in this proposal for
reasons of legal certainty.

The provision conferring presumption of
conformity to harmonised standards has been modified to clarify the extent of
the presumption of conformity when standards only partially cover the essential
requirements.

3.3.
Conformity assessment and CE marking

Council Directive 93/15/EEC on the
harmonization of the provisions relating to the placing on the market and
supervision of explosives for civil uses has selected the appropriate
conformity assessment procedures which manufacturers have to apply in order to
demonstrate that their explosives comply with the essential safety
requirements. The proposal aligns these procedures to their updated versions
set out in the NLF Decision.

General principles of the CE marking are
set out in Article 30 of Regulation 765/2008, while the detailed provisions on
the affixing of the CE marking to explosives have been inserted in this
proposal.

3.4.
Notified Bodies

The proposal reinforces the notification
criteria for notified bodies. It clarifies that subsidiaries or subcontractors
must also comply with the notification requirements. Specific requirements for
notifying authorities are introduced, and the procedure for notification of
notified bodies is revised. The competence of a notified body must be
demonstrated by an accreditation certificate. Where accreditation has not been
used to evaluate the competence of a notified body, the notification must
comprise the documentation demonstrating how the competence of that body has
been evaluated. Member States will have the possibility to object to a notification.

3.5.
Market surveillance and the safeguard clause
procedure

The proposal revises the existing safeguard
clause procedure. It introduces a phase of information exchange between Member
States, and specifies the steps to be taken by the authorities concerned, when
a non-compliant explosive is found. A real safeguard clause procedure – leading
to a Decision at Commission level on whether a measure is justified or not – is
only launched when another Member State objects to a measure taken against an
explosive. Where there is no disagreement on the restrictive measure taken, all
Member States must take the appropriate action on their territory.

3.6.
Comitology

The provisions on the operation of the
Explosives Committee have been adapted to the new provisions on implementing
acts laid down in Regulation (EU) No 182/2011 of the European Parliament and of
the Council of 16 February 2011 laying down the rules and general principles
concerning mechanisms for control by the Member States of the Commission's
exercise of implementing powers[3].

4.
legal elements of the proposal

Legal basis

The proposal is based on Article 114 of the
Treaty on the Functioning of the European Union.

Subsidiarity principle

The internal market is a competence that is
shared between the Union and the Member States. The subsidiarity principle
arises in particular with regard to the newly added provisions aiming at the
improvement of effective enforcement of Council Directive 93/15/EEC on the
harmonization of the provisions relating to the placing on the market and
supervision of explosives for civil uses, namely, the importer and distributor
obligations, the traceability provisions, the provisions on the assessment and
notification of notified bodies, and the enhanced cooperation obligations in the
context of the revised market surveillance and safeguard procedures.

Experience with the enforcement of the
legislation has shown that measures taken at national level have led to
divergent approaches and to a different treatment of economic operators inside
the EU, which undermines the objective of this directive. If actions are taken
at national level to address the problems, this risks creating obstacles to the
free movement of goods. Furthermore action at national level is limited to the
territorial competence of a Member State. In view of the increasing
internationalisation of trade, the number of cross-border cases is constantly
rising. Coordinated action at EU level can much better achieve the objectives
set, and will in particular render market surveillance more effective. Hence it
is more appropriate to take action at EU level.

As regards the problem of inconsistencies
throughout the directives, this is a problem which can only be solved by the EU
legislator.

Proportionality

In accordance with the principle of
proportionality, the proposed modifications do not go beyond what is necessary
to achieve the objectives set.

The new or modified obligations do not
impose unnecessary burdens and costs on industry – especially on small and
medium sized enterprises – or administrations. Where modifications have been
identified to have negative impacts, the analysis of the impacts of the option
serves to provide the most proportionate response to the problems identified. A
number of modifications concern the improvement of clarity of the existing
Directive without introducing new requirements that entail added cost.

Legislative technique used

The alignment to the NLF Decision requires
a number of substantive amendments to the provisions of Council Directive
93/15/EEC. To ensure the readability of the amended text the technique of
recasting has been chosen in line with the Interinstitutional Agreement of 28 November
2001 on a more structured use of the recasting technique for legal acts[4].

The changes made to the provisions of Council
Directive 93/15/EEC concern: the definitions, the obligations of economic
operators, the presumption of conformity provided by harmonised standards, the
declaration of conformity, CE marking, notified bodies, the safeguard clause
procedure and the conformity assessment procedures.

The proposal does not change the scope of Council
Directive 93/15/EEC and the essential safety requirements.

5.
budgetary implications

This proposal does not have any
implications for the EU budget.

6.
additional information

Repeal of existing legislation

The adoption of the proposal will lead to
repeal of Council Directive 93/15/EEC on the harmonization of the provisions
relating to the placing on the market and supervision of explosives for civil
uses.

European Economic Area

The proposal concerns the EEA and should
therefore be extended to the European Economic Area.

ê 93/15/EEC
(adapted)

ð new

NEW LEGISLATIVE FRAMEWORK (NLF)
ALIGNEMENT PACKAGE
(Implementation of the Goods Package)

2011/0349 (COD)

Proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

on the harmoniszation of the Ö laws of
the Member States Õ provisions
relating to the placing ð making available ï on the market and supervision of explosives for civil uses

(Recast)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty Ö on the
Functioning of the European Union Õ establishing the
European Economic Community, and in particular Article Ö 114 Õ 100a
thereof,

Having regard to the proposal from the
European Commission,

After transmission of the draft legislative
act to the national Parliaments,

Having regard to the opinion of the European
Economic and Social Committee[5],

Acting in accordance with the ordinary
legislative procedure,

Whereas:

ò new

(1)
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[6] has been substantially amended
several times. Since further amendments are to be made, it should be recast in
the interests of clarity.

(2)
Regulation (EC) No
765/2008 of the European Parliament and of the Council of 9 July 2008 setting
out the requirements for accreditation and market surveillance relating to the
marketing of products and repealing Regulation (EEC) No 339/93[7] lays down rules on the
accreditation of conformity assessment bodies, provides a framework for the
market surveillance of products and for controls on products from third
countries, and lays down the general principles of the CE marking.

(3)
Decision No
768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a
common framework for the marketing of products, and repealing Council Decision
93/465/EEC[8],
lays down common principles and reference provisions intended to apply across
the legislation harmonising the conditions for the marketing of products in
order to provide a coherent basis for revision or recasts of that legislation.
Directive 93/15/EEC should be adapted to that Decision.

ê 93/15/EEC
recital 1 (adapted)

Whereas Article 8a of the Treaty provides that the
internal market must be established not later than 31 December 1992; whereas
the internal market is to comprise an area without internal frontiers in which
the free movement of goods, persons, services and capital is ensured in
accordance with the provisions of the Treaty;

ê 93/15/EEC
recital 2 (adapted)

Whereas Article 100a (3) of the Treaty provides
that the Commission, in its proposals concerning safety, will take as a base a
high level of protection;

ê 93/15/EEC
recital 9 (adapted)

ð new

(4)
ð Safety during storage is covered by
Council Directive 96/82/EC of 9 December 1996 on the control of
major-accident hazards involving dangerous substances[9] which sets out safety
requirements for establishments where explosives are present. ïAs regards Ssafety, the rules concerning
the transport of explosives Ö during
transport is regulated Õ are covered
by international conventions and agreements. Ö including
the Õ At international level,
there are United Nations recommendations on the transport of
dangerous goods. Ö Those
aspects should therefore not fall under the scope of this Directive Õ (including explosives),
the scope of which extends beyond the Community framework. In consequence, this
Directive does not concern the transport rules.

ê 93/15/EEC
recital 12 (adapted)

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

(5)
The scope of this Directive covers Ö should
cover Õ ammunition,
but only as regards the rules governing controls on transfers and the
associated arrangements. Since ammunition is transferred under conditions
similar to those under which arms are transferred, transfers of ammunition
should be governed by provisions similar to those applicable to arms, as set
out in Council Directive 91/477/EEC of 18 June 1991 on control of the
acquisition and possession of weapons è1 [10] ç .

ê 93/15/EEC
recital 10 (adapted)

(6)
Pyrotechnical
articles require appropriate measures to ensure the protection of consumers and
the safety of the public. An additional directive is planned in this field. Ö Pyrotechnic
articles are covered by 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[11]. This Directive should
therefore not apply to pyrotechnic articles. Õ

ê 93/15/EEC
recital 11 (adapted)

(7)
The definition of the Ö explosives Õ products
covered by this Directive should be based on the definition of such products as
set out in the Ö United
Nations Õ abovementioned
recommendations Ö on the
transport of dangerous goods Õ.;

ê 93/15/EEC
recital 3 (adapted)

ð new

(8)
Ö In order
to ensure Õ The free movement of goods
presupposes that certain basic conditions are fulfilled.In particular,
the free movement of explosives Ö it is
necessary to harmonise Õ presupposes harmonization
of Ö the Õ laws Ö relating
to Õ on the placing of ð making ï explosives ð available ï on the market.

ê 93/15/EEC
recital 4

Whereas explosives
for civil uses are covered by detailed national regulations, mainly in respect
of safety and security requirements; whereas such national regulations
provide, in particular, that marketing authorizations be granted only where
explosives have satisfactorily undergone a series of tests;

ê 93/15/EEC
recital 5 (adapted)

Whereas harmonization of provisions governing
the placing of such explosives on the market presupposes that divergent
national rules will be harmonized in order to ensure the free movement of these
products without lowering optimum levels of safety and security;

ê 93/15/EEC
recital 6 (adapted)

Whereas this Directive defines only the essential
requirements which must be met by explosives conformity tests; whereas, in
order to facilitate the process of demonstrating compliance with the essential
requirements, it would be very useful to process standards harmonized at
European level concerning, inter alia,
methods for testing explosives; whereas such standards do not exist at present;

ê 93/15/EEC
recital 7 (adapted)

Whereas standards harmonized at European level
are drawn up by private bodies and must retain their status as non-mandatory
text; whereas, in this connection, the European Committee for Standardization
(CEN) has been recognized as one of the two bodies competent to adopt
harmonized standards in accordance with the
general guidelines for cooperation between the Commission and CEN and Cenelec,
ratified on 13 November 1984; whereas, for the purposes of this Directive,
«harmonized standard» means a text setting out technical specifications adopted
by CEN under a mandate conferred by the Commission, in accordance with Council
Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision
of information in the field of technical standards and regulations[12] and in
keeping with the abovementioned general guidelines;

ê 93/15/EEC
recital 13

the health and
safety of workers producing or using explosives must also be protected; whereas
an additional directive is in the course of preparation covering, inter alia, the health and safety of workers engaged in activities relating to the
manufacture, storage and use of explosives;

ò new

(9)
Economic operators
should be responsible for the compliance of explosives, in relation to their
respective roles in the supply chain, so as to ensure a high level of
protection of public interests, such as health and safety of persons and public
security and to guarantee fair competition on the Union market.

(10)
All economic operators
intervening in the supply and distribution chain should take appropriate
measures to ensure that they only make available on the market explosives which
are in conformity with this Directive. It is necessary to provide for a clear
and proportionate distribution of obligations which correspond to the role of each
operator in the supply and distribution process.

(11)
The manufacturer,
having detailed knowledge of the design and production process, is best placed
to carry out the complete conformity assessment procedure. Conformity
assessment should therefore remain the obligation of the manufacturer alone.

(12)
It is necessary to
ensure that explosives from third countries entering the Union market comply
with the requirements of this Directive, and in particular that appropriate
assessment procedures have been carried out by manufacturers with regard to
those explosives. Provision should therefore be made for importers to make sure
that the explosives they place on the market comply with the requirements of
this Directive and that they do not place on the market explosives which do not
comply with such requirements or present a risk. Provision should also be made
for importers to make sure that conformity assessment procedures have been
carried out and that marking and documentation of explosives drawn up by
manufacturers are available for inspection by the supervisory authorities.

(13)
The distributor makes
an explosive available on the market after it has been placed on the market by
the manufacturer or the importer and should act with due care to ensure that
its handling of the explosive does not adversely affect the compliance of the
explosive.

(14)
Any economic operator
that either places an explosive on the market under his own name or trademark or
modifies an explosive in such a way that compliance with the requirements of
this Directive may be affected should be considered to be the manufacturer and
should assume the obligations of the manufacturer.

(15)
Distributors and
importers, being close to the market place, should be involved in market
surveillance tasks carried out by the competent national authorities, and
should be prepared to participate actively, providing those authorities with
all necessary information relating to the explosive concerned.

(16)
Unique identification
of explosives is essential if accurate and complete records of explosives are
to be kept at all stages of the supply chain. This should allow the
identification and the traceability of an explosive from its production site
and its placing on the market until its final user and its use with a view to
preventing misuse and theft and to assisting law enforcement authorities in the
tracing of the origin of lost or stolen explosives. An efficient traceability
system also facilitates market surveillance authorities' task of tracing
economic operators who made non-compliant products available on the market.

(17)
The provisions of this
Directive relating to the making available on the market should be based on the
expression of essential safety requirements for explosives in order to protect
users and to prevent accidents. In order to facilitate conformity assessment
with those requirements it is necessary to provide for presumption of
conformity for explosives which
are in conformity with
harmonised standards that are adopted in accordance with Regulation (EU) No [../..] of the European
Parliament and of the Council of [.....] on European Standardisation and amending
Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC,
95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/105/EC and
2009/23/EC of the European Parliament and of the Council for the purpose of expressing detailed
technical specifications for the design, manufacture and testing of explosives[13].

(18)
(EU) No [../..]
[Standardisation Regulation] provides for a procedure for objections to
harmonised standards where those standards do not entirely satisfy requirements
of this Directive.

ê 93/15/EEC
recital 8 (new)

the Council, in
its Decision 90/683/EEC of 13 December 1990 concerning the modules for the
various phases of the conformity assessment procedures which are intended to
be used in the technical harmonization directives[14], introduced harmonized means of applying
procedures for conformity assessment; whereas the application of these modules
to explosives will make it possible to determine the responsibility of
manufacturers and of bodies responsible for applying procedures for conformity
assessment by taking account of the nature of the explosives concerned;

ò new

(19)
In order to enable
economic operators to demonstrate and the competent authorities to ensure that
explosives made available on the market conform to the essential safety
requirements it is necessary to provide for conformity assessment procedures.
Decision No 768/2008/EC establishes modules for conformity assessment
procedures which include procedures from the least to the most stringent, in
proportion to the level of risk involved and the level of safety required. In
order to ensure inter-sectoral coherence and to avoid ad-hoc variants
conformity assessment procedures should be chosen from among those modules. Because
of their specific characteristics and the hazards involved, explosives should
always be submitted to third party verification - EU type examination. Manufacturers
should draw up an EU declaration of conformity to provide detailed information on
the conformity of an explosive with the requirements of the relevant Union
harmonisation legislation.

(20)
The CE marking,
indicating the conformity of a product, is the visible consequence of a whole
process comprising conformity assessment in a broad sense. General principles
governing the CE marking are set out in Regulation (EC) No 765/2008. Rules
governing the affixing of the CE marking should be laid down in this Directive.

(21)
The conformity
assessment procedures set out in this Directive require the intervention of
conformity assessment bodies, which are notified by the Member States to the
Commission.

(22)
Experience has shown
that the criteria set out in Directive 93/15/EEC that conformity assessment
bodies have to fulfil to be notified to the Commission are not sufficient to
ensure a uniformly high level of performance of notified bodies throughout the
Union. It is, however, essential that all notified bodies perform their
functions to the same level and under conditions of fair competition. That
requires the setting of obligatory requirements for conformity assessment
bodies wishing to be notified in order to provide conformity assessment
services.

(23)
In order to ensure a
consistent level of conformity assessment quality it is also necessary to set
requirements for notifying authorities and other bodies involved in the
assessment, notification and monitoring of notified bodies.

(24)
If a conformity
assessment body demonstrates conformity with the criteria laid down in harmonised
standards, it should be presumed to comply with the corresponding requirements
set out in this Directive.

(25)
The system set out in
this Directive should be complemented by the accreditation system provided for
in Regulation (EC) No 765/2008. Since accreditation is an essential means of
verifying the competence of conformity assessment bodies, it should also be
used for the purposes of notification.

(26)
Transparent
accreditation as provided for in Regulation (EC) No 765/2008, ensuring the
necessary level of confidence in conformity certificates, should be considered
by the national public authorities throughout the Union as the preferred means
of demonstrating the technical competence of conformity assessment bodies.
However, national authorities may consider that they possess the appropriate
means of carrying out this evaluation themselves. In such cases, in order to
ensure the appropriate level of credibility of evaluations carried out by other
national authorities, they should provide the Commission and the other Member
States with the necessary documentary evidence demonstrating the compliance of
the conformity assessment bodies evaluated with the relevant regulatory
requirements.

(27)
Conformity assessment
bodies frequently subcontract parts of their activities linked to the
assessment of conformity or have recourse to a subsidiary. In order to
safeguard the level of protection required for the products to be placed on the
Union market, it is essential that conformity assessment subcontractors and
subsidiaries fulfil the same requirements as notified bodies in relation to the
performance of conformity assessment tasks. Therefore, it is important that the
assessment of the competence and the performance of bodies to be notified and
the monitoring of bodies already notified cover also activities carried out by
subcontractors and subsidiaries.

(28)
It is necessary to
increase the efficiency and transparency of the notification procedure and, in
particular, to adapt it to new technologies so as to enable online notification.

(29)
Since notified bodies
may offer their services throughout the Union, it is appropriate to give the
other Member States and the Commission the opportunity to raise objections
concerning a notified body. It is therefore important to provide for a period
during which any doubts or concerns as to the competence of conformity
assessment bodies can be clarified before they start operating as notified
bodies.

(30)
In the interests of
competitiveness, it is crucial that notified bodies apply the conformity
assessment procedures without creating unnecessary burdens for economic
operators. For the same reason, and to ensure equal treatment of economic
operators, consistency in the technical application of the conformity
assessment procedures needs to be ensured. That can best be achieved through
appropriate coordination and cooperation between notified bodies.

(31)
In order to ensure
legal certainty, it is necessary to clarify that rules on Union market
surveillance and control of products entering the Union market provided for in
Regulation (EC) No 765/2008 apply to explosives. This Directive should not
prevent Member States from choosing the competent authorities to carry out
those tasks.

(32)
The existing system
should be supplemented by a procedure under which interested parties are
informed of measures intended to be taken with regard to products presenting a
risk to the health and safety of persons or to other aspects of public interest
protection. It should also allow market surveillance authorities, in
cooperation with the relevant economic operators, to act at an earlier stage in
respect of such products.

(33)
Where the Member
States and the Commission agree as to the justification of a measure taken by a
Member State, no further involvement of the Commission should be required, except
where non-compliance can be attributed to shortcomings of a harmonised
standard.

ê 93/15/EEC
recital 14 (adapted)

(34)
It is appropriate Iin
the case of a serious threat to, or attack on, public Ö security
as a result of Õ safety by reason of the illicit
possession or use of explosives or ammunition falling within this Directive, to allow
Member States Ö should be
allowed Õ to derogate,
under certain conditions, from the provisions of this Directive with regard to
transfer Ö of
explosives and ammunition in order to prevent such illicit possession or
use Õ.

ê 93/15/EEC
recital 15 (adapted)

(35)
Finally, Iit
is essential to establish administrative cooperation mechanisms Ö between
competent authorities of Member States Õ. Ö Therefore, Õ It is appropriate in this
connection for the competent authorities Ö should Õ to base
their approach on Council Regulation (EEC) No 1468/81 of 19 May 1981
(EC) No 515/97 of 13 March 1997
on mutual assistance between the administrative authorities of the Member
States and cooperation between the latter and the Commission to ensure the
correct application of the law on customs and Ö or Õ agricultural
matters[15].

ê 93/15/EEC
recital 16 (adapted)

(36)
This Directive does Ö should Õ not affect the
power of Member States to take measures with a view to preventing illegal trade
in explosives and ammunition.

ò new

(37)
In order to ensure
uniform conditions for the implementation of this Directive, implementing
powers should be conferred on the Commission. Those powers should be exercised
in accordance with Regulation (EU) No 182/2011 of the European Parliament and
of the Council of 16 February 2011 laying down the rules and general principles
concerning mechanisms for control by the Member States of the Commission's
exercise of implementing powers[16].

(38)
The examination
procedure should be used for the adoption of the implementing acts in order to set
up the conditions for a system for identification and keeping track of
explosives.

(39)
In order to achieve
the objectives of this Directive, the power to adopt acts in accordance with
Article 290 of the Treaty on the Functioning of the European Union should be
delegated to the Commission in respect of adopting Union measures concerning
adapting this Directive to United Nations recommendations on the transport of
dangerous goods. It is of particular importance that the Commission carry out
appropriate consultations during its preparatory work, including at expert
level.

(40)
The Commission, when
preparing and drawing-up delegated acts, should ensure a simultaneous, timely
and appropriate transmission of relevant documents to the European Parliament
and Council.

(41)
The Member States
should lay down rules on penalties applicable to infringements of the national
provisions adopted pursuant to this Directive and ensure that they are
implemented. Those penalties should be effective, proportionate and dissuasive.

(42)
Since the objective of
this Directive, namely to ensure that explosives on the market fulfil the
requirements providing a high level of protection of health and safety and
other public interests while guaranteeing the functioning of the internal
market cannot be sufficiently achieved by the Member States and can therefore,
by reason of its scale and effects, be better achieved at Union level, the Union
may adopt measures, in accordance with the principle of subsidiarity as set out
in Article 5 of the Treaty on European Union. In accordance with the principle
of proportionality, as set out in that Article, this Directive does not go
beyond what is necessary in order to achieve that objective.

(43)
It is necessary to
provide for transitional arrangements that allow making available on the market
explosives that have already been placed on the market in accordance with
Directive 93/15/EEC.

(44)
The
obligation to transpose this Directive into national law should be confined to
those provisions which represent a substantive change as compared with
Directive 93/15/EEC. The obligation to transpose the provisions
which are unchanged arises under Directive 93/15/EEC.

(45)
This Directive
should be without prejudice to the obligations of the Member States relating to
the time-limits for transposition into national law and application of Directive
93/15/EEC.

ê 93/15/EEC
(adapted)

HAS Ö HAVE Õ ADOPTED THIS
DIRECTIVE:

CHAPTER 1I

General Provisions

Article 1
 Ö Scope Õ

1. This Directive shall apply to Ö the
following: Õ explosives as defined in
paragraph 2.

ò new

(a)
explosives for civil
uses;

(b)
transfer of ammunition
and information exchange on those transfers referred to in Articles 12, 13 and
14.

ê 93/15/EEC

32. This Directive shall not apply to:

ê 93/15/EEC
(adapted)

(a)          explosives Ö and Õ , including
ammunition, intended for use, in accordance with national law, by the armed
forces or the police;,

(b)          pyrotechnical
articles Ö falling
within the scope of Directive 2007/23/EC. Õ

ê 93/15/EEC

–
ammunition, except
as provided in Articles 10, 11, 12, 13, 17, 18 and 19.

ê 93/15/EEC
(adapted)

ð new

53.         This Directive shall not prevent Member States from
designating certain substances not covered by this Directive as explosives
under national law
Ö laws Õ or
regulations.

Article
2 [Article R1 of Decision No 768/2008/EC]
 Ö Definitions Õ

4. For the purposes of this Directive Ö the
following definitions shall apply Õ :

(1)          2. ‘«eExplosives’» shall mean Ö means Õ the materials
and articles considered to be such in the United Nations recommendations on the
transport of dangerous goods and falling within Class 1 of those
recommendations;.

(2)          ‘«United
Nations recommendations’»
shall
mean
Ö means Õ the
recommendations laid down by the United Nations Committee of Experts on the
Transport of Dangerous Goods, as published in the United Nations
(Orange Book) and as amended by the date when this Directive is adopted;,

(3)          ‘«safety’» shall mean Ö means Õ the prevention
of accidents and, where prevention fails, the containment of their effects;,

(4)          ‘«security’» shall mean Ö means Õ the prevention
of use contrary to law and order;,

(5)          ‘«dealer’» shall mean Ö means Õ any natural or
legal person whose occupation consists wholly or partly in the manufacture, trade,
exchange, hiring out, repair or conversion of fire arms and ammunition,

(6)          ‘«approval’» shall mean Ö means Õ the decision
taken to allow envisaged transfers of explosives within the Ö Union Õ Community;,

(7)          «undertaking in the explosives
sector» ð ‘economic operators’ ï shall
mean
Ö means Õ ð the manufacturer, the authorised
representative, the importer, the distributor and ï any natural or legal person possessing a
licence or authorization which entitles him to Ö who engages Õ engage
in the manufacture, storage,
use, transfer, ð export ï or trade Ö of Õ in
explosives;,

(8)          «‘transfer’»
shall
mean
Ö means Õ any physical
movement of explosives within Ö the Union Õ Community territory
Ö except Õ apart from
movements within one and the same site;.

(9)          «‘placing
ð making available ï on the market’»
shall
mean
Ö means Õ any first disposal against payment or free of charge
ð supply ï of Ö an explosive Õ explosives
covered by this Directive
Ö for Õ with a view to their
distribution and/or
use on the Community
Ö Union Õ market ð in the course of a commercial
activity, whether in return for payment or free of charge; ï ,

ò new

(10)        ‘placing
on the market’ means the first making available of an explosive on the Union
market;

(11)        ‘manufacturer’
means any natural or legal person who manufactures an explosive or has an
explosive designed or manufactured, and markets explosives under his name or
trademark;

(12)        ‘authorised
representative’ means any natural or legal person established within the Union
who has received a written mandate from a manufacturer to act on his behalf in
relation to specified tasks;

(13)        ‘importer’
means any natural or legal person established within the Union who places
explosives from a third country on the Union market;

(14)        ‘distributor’
means any natural or legal person in the supply chain, other than the
manufacturer or the importer, who makes explosives available on the market;

(15)        ‘technical
specification’ means a document that prescribes technical requirements to be
fulfilled by an explosive;

(16)        ‘harmonised
standard’ means harmonised standard as defined in Article 2(1)(c) of Regulation
(EU) No [../..] [Standardisation Regulation];

(17)        ‘accreditation’
means accreditation as defined in Article 2(10) of Regulation (EC) No 765/2008;

(18)        ‘national
accreditation body’ means national accreditation body as defined in Article
2(11) of Regulation (EC) No 765/2008;

(19)        ‘conformity
assessment’ means the process demonstrating whether the essential safety
requirements relating to an explosive have been fulfilled;

(20)        ‘conformity
assessment body’ means a body that performs conformity assessment activities
including calibration, testing, certification and inspection;

(21)        ‘recall’
means any measure aimed at achieving the return of an explosive that has
already been made available to the end user;

(22)        ‘withdrawal’
means any measure aimed at preventing an explosive in the supply chain from
being made available on the market;

(23)        ‘CE
marking’ means a marking by which the manufacturer indicates that the explosive
is in conformity with the applicable requirements set out in Union
harmonisation legislation providing for its affixing;

(24)        ‘Union
harmonisation legislation’ means any Union legislation harmonising the
conditions for the marketing of products.

ê 93/15/EEC (adapted)

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

ð new

CHAPTER II

Harmonization of laws relating to explosives

Article 32
Ö Free
movement Õ

1. Member States may not prohibit, restrict or hinder the placing ð making available ï on the market of explosives which fall within the scope of this Directive and which
satisfy the requirements of this Directive.

Article 4
Ö Making
available on the market Õ

2. Member States shall take the necessary measures to ensure that
explosives falling
within the scope of this Directive may be ð made available ï placed on the market only
if they comply
with all the provisions of this Directive, are provided with the CE marking
described in Article 7 and their conformity è1 has been assessed ç in accordance
with the procedures referred to in Annex II.

3. Where
explosives falling within the scope of this Directive are subject to other
Directives which cover other aspects and prescribe the fixing of the CE
marking, this marking shall indicate that the abovementioned products are also
presumed to conform to the provisions of these other directives which apply to them.

Article 3

Explosives falling within the scope of this
Directive must comply with the essential safety ð all the ï requirements Ö of this
Directive Õ set out in Annex I
which apply to them.

CHAPTER 2

Ö Obligations
of Economic Operators Õ

Article 514
 Ö Licence
and authorisation Õ

Member States
shall keep at the disposal of the other Member States and the Commission
updated information concerning undertakings in the explosives sector possessing
licences or authorizations as referred to in Article 1(4).

ò new

Economic
operators shall be in possession of a licence or authorisation which entitles
them to engage in the manufacture, storage, use, import, export, transfer or
trade of explosives.

The first
paragraph shall not apply to employees of an economic operator possessing a
licence or authorisation.

Article 6
[Article R2 of Decision No 768/2008/EC]
Obligations of manufacturers

1.
When placing explosives
on the market or when using explosives themselves, manufacturers shall ensure
that they have been designed and manufactured in accordance with the essential
safety requirements set out in Annex I.

2.
Manufacturers shall
draw up the technical documentation referred to in Annex II and carry out the
conformity assessment procedure referred to in Article 19 or have it carried
out.

Where compliance of
an explosive with the applicable requirements has been demonstrated by that
procedure, manufacturers shall draw up an EU declaration of conformity and
affix the CE marking.

The CE marking does
not need to be affixed on explosives manufactured for own use, explosives
transported and delivered unpackaged or in pump trucks for their direct
unloading into the blast-hole, and explosives manufactured at the blasting
sites which are loaded immediately after being produced (so-called in situ
production).

3.
Manufacturers shall
keep the technical documentation and the EU declaration of conformity for at
least 10 years after the explosive has been placed on the market.

4.
Manufacturers shall
ensure that procedures are in place for series production to remain in
conformity. Changes in design or characteristics of the explosive and changes
in the harmonised standards or in technical specifications by reference to
which conformity of an explosive is declared shall be adequately taken into
account.

5.
Manufacturers
shall ensure that their explosives bear the unique identification in accordance
with Commission Directive 2008/43/EC[17].

6.
Manufacturers shall
ensure that their explosives are accompanied by instructions and safety
information in a language which can be easily understood by end-users, as
determined by the Member State concerned.

7.
Manufacturers who
consider or have reason to believe that an explosive which they have placed on
the market is not in conformity with this Directive shall immediately take the
necessary corrective measures to bring that explosive into conformity, to
withdraw it or recall it, if appropriate. Furthermore, where the explosive
presents a risk, manufacturers shall immediately inform the competent national
authorities of the Member States in which they made the explosive available to
that effect, giving details, in particular, of the non-compliance and of any
corrective measures taken.

8.
Manufacturers shall,
further to a reasoned request from a competent national authority, provide it
with all the information and documentation necessary to demonstrate the
conformity of the explosive, in a language which can be easily understood by
that authority. They shall cooperate with that authority, at its request, on
any action taken to eliminate the risks posed by explosives which they have
placed on the market.

Article 7
[Article R3 of Decision No 768/2008/EC]
Authorised representatives

1.
A manufacturer may, by
a written mandate, appoint an authorised representative.

The obligations laid
down in Article 6(1) and the drawing up of technical documentation shall not
form part of the authorised representative's mandate.

2.
An authorised
representative shall perform the tasks specified in the mandate received from
the manufacturer. The mandate shall allow the authorised representative to do
at least the following:

(a)
keep the EU
declaration of conformity and the technical documentation at the disposal of
national surveillance authorities for 10 years after the explosive has been
placed on the market;

(b)
further to a reasoned
request from a competent national authority, provide that authority with all
the information and documentation necessary to demonstrate the conformity of an
explosive;

(c)
cooperate with the
competent national authorities, at their request, on any action taken to
eliminate the risks posed by explosives covered by the authorised representative's
mandate.

Article 8
[Article R4 of Decision No 768/2008/EC]
Obligations of importers

1.
Importers shall place
only compliant explosives on the market.

2.
Before placing an
explosive on the market importers shall ensure that the appropriate conformity
assessment procedure has been carried out by the manufacturer. They shall
ensure that the manufacturer has drawn up the technical documentation, that the
explosive bears the CE marking and is accompanied by the required documents.

Where an importer
considers or has reason to believe that an explosive is not in conformity with
the essential safety requirements set out in Annex I, he shall not place the
explosive on the market until it has been brought into conformity. Furthermore,
where the explosive presents a risk, the importer shall inform the manufacturer
and the market surveillance authorities to that effect.

3.
Importers shall ensure
that the explosives imported by them bear a unique identification in accordance
with Directive 2008/43/EC.

4.
Importers shall ensure
that the explosive is accompanied by instructions and safety information in a
language which can be easily understood by end-users, as determined by the
Member State concerned.

5.
Importers shall ensure
that, while an explosive is under their responsibility, storage or transport
conditions do not jeopardise its compliance with the essential safety
requirements set out in Annex I.

6.
Importers who consider
or have reason to believe that an explosive which they have placed on the
market is not in conformity with the requirements of this Directive shall
immediately take the corrective measures necessary to bring that explosive into
conformity, to withdraw it or recall it, if appropriate. Furthermore, where the
explosive presents a risk, importers shall immediately inform the competent
national authorities of the Member States in which they made the explosive
available to that effect, giving details, in particular, of the non-compliance
and of any corrective measures taken.

7.
Importers shall, for
at least 10 years after the explosive has been placed on the market, keep a
copy of the EU declaration of conformity at the disposal of the market
surveillance authorities and ensure that the technical documentation can be
made available to those authorities, upon request.

8.
Importers shall,
further to a reasoned request from a competent national authority, provide it
with all the information and documentation necessary to demonstrate the
conformity of an explosive in a language which can be easily understood by that
authority. They shall cooperate with that authority, at its request, on any
action taken to eliminate the risks posed by explosives which they have placed
on the market.

Article 9
[Article R5 of Decision No 768/2008/EC]
Obligations of distributors

1.
When making an explosive
available on the market distributors shall act with due care in relation to the
requirements of this Directive.

2.
Before making an
explosive available on the market distributors shall verify that the explosive
bears the CE marking, that it is accompanied by the required documents and by
instructions and safety information in a language which can be easily
understood by end-users in the Member State in which the explosive is to be
made available on the market, and that the manufacturer and the importer have
complied with the requirements set out in Directive 2008/43/EC.

Where a distributor
considers or has reason to believe that an explosive is not in conformity with
the essential safety requirements set out in Annex I, he shall not make the
explosive available on the market until it has been brought into conformity.
Furthermore, where the explosive presents a risk, the distributor shall inform
the manufacturer or the importer to that effect as well as the market
surveillance authorities.

3.
Distributors shall
ensure that, while an explosive is under their responsibility, storage or
transport conditions do not jeopardise its compliance with the essential safety
requirements set out in Annex I.

4.
Distributors who
consider or have reason to believe that an explosive which they have made
available on the market is not in conformity with this Directive shall make
sure that the corrective measures necessary to bring that explosive into
conformity, to withdraw it or recall it, if appropriate, are taken. Furthermore,
where the explosive presents a risk, distributors shall immediately inform the
competent national authorities of the Member States in which they made the
explosive available 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 a competent national authority, provide it
with all the information and documentation necessary to demonstrate the
conformity of an explosive. They shall cooperate with that authority, at its
request, on any action taken to eliminate the risks posed by explosives which
they have made available on the market.

Article 10
Cases in which obligations of manufacturers apply to importers and
distributors

An importer or
distributor shall be considered a manufacturer for the purposes of this
Directive and he shall be subject to the obligations of the manufacturer under
Article 6, where he places an explosive on the market under his name or
trademark or modifies an explosive already placed on the market in such a way
that compliance with this Directive may be affected.

ê 93/15/EEC
(adapted)

CHAPTER 3III

Ö Security Õ
Provisions governing
the supervision of transfers in the Community

Article 119
 Ö Transfers
of explosives Õ

1.           Explosives covered by this Directive
may be transferred only in accordance with the following paragraphs Ö 2 to
8 Õ.

ê 93/15/EEC

2. Controls
performed pursuant to Community law or national law in the event of
transfers of the explosives governed by this Article shall no longer be
performed as internal frontier controls but solely as part of the normal
control procedures applied in a non-discriminatory fashion throughout the territory of the Community.

ê 93/15/EEC
(adapted)

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

ð new

23.         Approval
to transfer explosives shall be obtained by the consignee from the recipient
competent authority Ö in the
Member State of the recipient Õ . The
competent authority shall verify that the consignee is legally authoriszed to acquire
explosives and that he is in possession of the necessary licences or authoriszations. The
person responsible for the transfer must notify the competent authorities of
the transit Member State
Ö State(s) Õ or Member States
of Ö any Õ movements of explosives through Ö the Member
States concerned Õ this or these States,
whose Ö and shall
obtain prior Õ approval shall be required
Ö of the
transit Member State(s) concerned Õ.

34.         Where
a Member State considers that there is a problem regarding the verification of
the entitlement to acquire explosives referred to in paragraph 23, that Member
State shall forward the available information on the subject to the Commission
which ð shall inform the other Member States
thereof ï will
put the matter before the Committee provided for in è1 Article 13 ç without delay.

45.         Where
the recipient
competent authority Ö in the
Member State of the recipient Õ approves a
transfer, it shall issue to the consignee a document which includes all the
information referred to in paragraph 57.
Such a document must accompany the explosives until they arrive at their stated
destination. It must be produced at the request of the relevant competent
authorities. A copy of Ö that Õ this
document shall be retained by the consignee who shall present it Ö , upon
request, Õ for
examination by the recipient
competent authority, at the latter's
request Ö in the
Member State of the recipient Õ .

ê 93/15/EEC
(adapted)

57.         Where
transfers of explosives must be specially supervised in order to comply with
special security requirements in the territory or part of the territory of a
Member State, prior to the transfer the following information shall be provided
by the consignee to the recipient competent authority Ö in the
Member State of the recipient Õ :

ê 93/15/EEC
(adapted)

(a)     the names and addresses of the operators concerned; this information must be
detailed enough to enable the operators to be contacted and confirmation to be
obtained that the persons in question are legally entitled to receive the
consignment,

ê 93/15/EEC

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

(b)     the number and quantity of the explosives being transferred;,

(c)     a full description of the explosive in question and of the
means of identification, including the United Nations identification number;,

(d)     where the explosives are to be placed on the market,
information on compliance with conditions for placing on the market;,

(e)     the means of transfer and the itinerary;,

(f)      the expected dates of departure and è1 arrival ç;,

(g)     where necessary, the precise points of entry to and exit from
Member States.

ê 93/15/EEC (adapted)

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

ð new

Ö The
information referred to in point (a) of the first subparagraph must be detailed
enough to enable the operators to be contacted and confirmation to be obtained
that the persons concerned are entitled to receive the consignment. Õ

RecipientÖ The Õ competent Ö authority Õ authorities
Ö in the
Member State of the recipient Õ shall examine
the conditions under which the transfer may take place, with particular regard
to the special security requirements. If the special security requirements are
satisfied, approval for the transfer shall be granted. In the Ö case Õ event
of transit through the territory of other Member States, those Ö Member Õ States shall
likewise examine and approve, in the same conditions, the particulars concerning
the transfer.

6.           Where the competent
authority of a Member State considers that special security requirements such as those
referred to in paragraph 54 ð and 5 ï are unnecessary, explosives can Ö may Õ be transferred
on their territory or part thereof without prior provision of information
within the meaning of paragraph 57.
The recipient
competent authority Ö in the
Member State of the recipient Õ shall then
grant an approval for a fixed period, Ö which
is Õ and
liable to suspension or withdrawal at any time on the basis of a reasoned
justification. The document referred to in paragraph 45, which must
accompany the explosives until they arrive at their destination, shall refer
solely to Ö that Õ the abovementioned
approval.

78.         Without
prejudice to the normal checks which the Member State of departure shall carry
out in its territory, at the request of the competent authorities concerned,
the consignees and the Ö economic Õ operators
concerned in the
explosives sector shall forward to the authorities of the
Member State of departure and to those of the Member State of transit all
relevant information they è1 possess ç concerning the
transfer of explosives.

89.         No
supplier may transfer explosives unless the consignee has obtained the
necessary authoriszations
for the transfer in accordance with the provisions of è1 paragraphs ç 23, 45, 56 and 67.

Article 1210
 Ö Transfers
of ammunition Õ

1.
Ammunition may be transferred from one Member
State to another only in accordance with the procedure laid down in the following
paragraphs Ö 2 to
5 Õ . These Ö Those Õ provisions
Ö paragraphs Õ shall also
apply to transfers of ammunition under mail-order sales.

ê 93/15/EEC

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

2.
Where ammunition is to be transferred to another
Member State the person concerned shall, before any dispatch, communicate to
the Member State in which that ammunition is located:

(a)     the names and addresses of the person selling or transferring
the ammunition, of the person purchasing or acquiring the ammunition and, where
appropriate, of the owner;,

(b)     the è1 address ç to which the
ammunition is to be consigned or transported;,

(c)     the quantity of ammunition to be consigned or transported;,

(d)     data making it possible to identify the ammunition and also an
indication that the ammunition has undergone a check in accordance with the
Convention of 1 July 1969 on the Reciprocal Recognition of Proofmarks on
Small Arms;,

(e)     the means of transfer;,

(f)      the date of departure and the estimated date of arrival.

ê 93/15/EEC
(adapted)

The information referred to in the
last two indents points
(e) and (f) of the first subparagraph need not be supplied in the Ö case Õ event
of a transfer between dealers. The Member State shall examine the conditions
under which the transfer is to be carried out, in particular with regard to
security. Where the Member State authoriszes
such a transfer it shall issue a licence incorporating all the particulars
referred to in the first subparagraph. That licence shall accompany the
ammunition until it reaches its destination.;
Iit shall be
produced whenever so required by the competent authorities of the Member
States.

ê 93/15/EEC

3.
Each Member State may grant dealers the right to
effect transfers of ammunition from its territory to a dealer established in
another Member State without the prior authoriszation
referred to in paragraph 2. To that end it shall issue an authoriszation valid for
three years which may at any time be suspended or cancelled by reasoned
decision. A document referring to that authoriszation
must accompany the ammunition until it reaches its destination. It must be
produced whenever so required by the competent authorities of the Member
States.

Before effecting the transfer, the dealer shall
communicate to the authorities of the Member State from which the transfer is
to be effected all the particulars listed in the first subparagraph of
paragraph 2.

4.
Each Member State shall supply the other Member
States with a list of the ammunition the transfer of which to its territory may
be authoriszed
without its prior consent.

ê 93/15/EEC
(adapted)

Such lists of ammunition shall be communicated
to dealers who have obtained approval for transferring ammunition without prior
authoriszation
Ö in
accordance with Õ under
the procedure laid down in paragraph 3.

ê 93/15/EEC

5.
Each Member State shall communicate all useful
information at its disposal concerning definitive transfers of ammunition to
the Member State, to the territory of which such a transfer has been effected.

ê 93/15/EEC
(adapted)

All information that Member States receive by way of the procedures
laid down in Ö accordance
with paragraphs 2 and 3 Õ this Article
shall be communicated, not later than the time of the relevant transfers, to
the Member States of destination and, where appropriate, not later than the
time of transfer to the Member States of transit.

Article 1311
 Ö Security
derogations Õ

By derogation from Article 119 (3), (5), (6)
and (7), and from Article 1210,
a Member State, in case of Ö serious Õ grave
threats to, or attacks upon, public security Ö as a
result of Õ through the
illicit possession or use of explosives or ammunition covered by the Directive, may
take all necessary measures concerning transfers of explosives or ammunition in
order to prevent such illicit possession or use.

These measures Ö referred
to in the first paragraph Õ shall respect
the principle of proportionality. They must constitute neither a means of
arbitrary discrimination nor a veiled restriction in trade between Member
States.

ê 93/15/EEC

Each Member State which adopts such
measures shall notify the Commission of them forthwith.; Tthe Commission
shall inform the other Member States thereof.

ê 93/15/EEC
(adapted)

CHAPTER IV

Other provisions

Article 1412
 Ö Information
exchange Õ

1. Member States shall set up information
exchange networks for the implementation of Articles 119 and 1210. They shall
notify the other Member States and the Commission of the national authorities
responsible for forwarding or receiving information and for applying the
procedures referred to in Ö those Õ the said
Articles 9 and 10.

ò new

Member States
shall keep at the disposal of the other Member States and of the Commission
updated information concerning economic operators possessing licences or
authorisations referred to in Article 5.

ê 93/15/EEC
(adapted)

2. For the purposes of implementing this Directive, the provisions of
Regulation
(EEC) No 1468/81 Regulation
(EC) No 515/97, in particular those Ö the requirements Õ relating to
confidentiality, shall apply mutatis mutandis.

ê (EC)
219/2009 (adapted)

ð new

Article
15
Ö Identification
and traceability of explosives Õ

Member States shall ascertain Ö that Õ whether such undertakings ð economic operators ï possess a system for keeping track of explosives such that those
holding explosives can be identified at any time.

ê (EC)
219/2009

ð new

The Commission may adopt measures ð implementing acts ï setting the conditions for the application of this
the first paragraph ð to set up a system for the unique
identification and traceability at Union level ï. Those measures, designed to amend
non-essential elements of this Directive by supplementing it,
ð implementing acts ï shall be adopted in accordance with the regulatory ð examination ï procedure with scrutiny referred to in
Article 13(4) 47(2).

ê 93/15/EEC

ð new

Undertakings in
the explosives sector ð Economic operators ï shall keep such records of their transactions as are necessary to
fulfil the obligations set out in the first
paragraph this Article.

The documents referred to in the first and second paragraph this
Article must be kept for at least three ð ten ï years after the end of the calendar year in which the recorded
transaction took place, even if the undertaking
ð economic operator ï has ceased trading. They must be immediately available for
inspection at the request of the competent authorities.

Article 15

Member States
shall ensure that explosives are properly marked.

ê 93/15/EEC
(adapted)

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

Article 16
 Ö Licensing
of manufacturing activities Õ

When a Member State issues a licence or è1 authoriszation ç Ö referred
to in Article 5 Õ for the purpose of allowing
an explosives manufacturing Ö of
explosives Õ activity to be exercised,
it shall check in particular that the persons responsible are capable of
complying with the technical commitments they assume.

Article 1718
 Ö Seizures Õ

Each Member State shall adopt, in the context of its
national law, the necessary measures to enable the competent
authorities to seize any Ö explosive Õ product coming within the
scope of this Directive if there is sufficient evidence
that that Ö explosive Õ product
will be è1 illicitly ç acquired, used
or dealt in.

ê 93/15/EEC
(adapted)

Chapter 4

Ö Conformity
of the Explosive Õ

Article 184
[Article R8 of Decision No 768/2008/EC]
 Ö Presumption
of conformity Õ

1.Member
States shall consider explosives falling within the scope of this Directive Ö Explosives, Õ which Ö are in
conformity Õ comply
with the relevant
national standards transposing the harmoniszed standards Ö or parts
thereof and Õ the references
of which have been published in the Official Journal of the European Communities
Ö Union,
shall be presumed Õ to be in
conformity with the essential safety requirements referred to in Article 3. Member States shall
publish the references of the national standards transposing
Ö covered
by Õ those harmonized
standards Ö or parts
thereof, set out in Annex I Õ.

ò new

Where a
harmonised standard satisfies the requirements which it covers and which are
set out in Annex I or Article 27, the Commission shall publish the references
of those standards in the Official Journal of the European Union.

ê 93/15/EEC

2. The Commission
will give specific details of the work conducted in the field of harmonized
standards in the framework of the report submitted to the European Parliament
and the Council on the application of Directive 83/189/EEC and provided for in
Article 11 (2) of that Directive.

Article 5

Where a Member
State or the Commission considers that the harmonized standards referred to
in Article 4 do not fully satisfy the essential requirements referred to in
Article 3, the Commission or the Member State concerned shall bring the matter
before the Standing Committee set up by
Directive 83/189/EEC, giving its reasons. The Committee shall deliver its
opinion without delay.

In the light of
the Committee's opinion the Commission shall inform the Member States of the
measures to be taken regarding the standards and the publication referred to
in Article 4.

ê 93/15/EEC
(adapted)

ð new

Article 196
 Ö Conformity
assessment procedures Õ

1.The procedures for the attestation Ö assessment Õ of the conformity
of explosives shall be Ö any of
the following procedures Õ either:

(a)
EC Ö EU Õ type
examination (Module B) Ö set
out Õ referred to
in Annex II (1), and, at the choice of the manufacturer, Ö any of
the following procedures Õ either:

(i)      the
type conformity ð to type based on internal production
control plus supervised product checks at random intervals ï (Module C2) Ö set
out Õ referred to
in Annex II (2),

(ii)     or
the production Ö conformity
to type based on Õ quality
assurance Ö of the
production process Õ procedure
(Module D) Ö set
out Õ referred to
in Annex II (3),

(iii)     or
the Ö conformity
to type based on Õ product
quality assurance procedure
(Module E) Ö set
out Õ referred to
in Annex II (4),

(iv)    or
the Ö conformity
to type based on Õ product
verification (Module F) Ö set
out Õ referred to
in Annex II (5);
or

(b)
the Ö conformity
based on Õ unit
verification (Module G) Ö set
out Õ referred to
in Annex II (6).

ò new

Article 20
[Article R10 of Decision No 768/2008/EC]
EU declaration of conformity

1.
The EU declaration of
conformity shall state that the fulfilment of the essential safety requirements
set out in Annex I has been demonstrated.

2.
The EU declaration of
conformity shall have the model structure set out in Annex III to Decision No
768/2008/EC, shall contain the elements specified in the relevant modules set
out in Annex II to this Directive and shall be continuously updated. It shall
be translated into the language or languages required by the Member State in
which market the explosive is placed or made available.

3.
Where an explosive is
subject to more than one Union act requiring an EU declaration of conformity, a
single EU declaration of conformity shall be drawn up in respect of all such
Union acts. That declaration shall contain the identification of the acts
concerned including the publication references.

4.
By drawing up the EU
declaration of conformity, the manufacturer shall assume responsibility for the
compliance of the explosive.

ê 93/15/EEC
(adapted)

ð new

ANNEX IV

CONFORMITY MARKING

Article
21 [Article R11 of Decision No 768/2008/EC]
 Ö General
principles of the CE marking Õ

The CE conformity marking shall ð be subject to the general principles
set out in Article 30 of Regulation (EC) No 765/2008. ï 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.

Article 227
[Article R12 of Decision No 768/2008/EC]
 Ö Rules
and conditions for affixing the CE marking Õ

1.           The CE marking of conformity
shall be affixed Ö visibly,
legibly and indelibly to Õ in such a way as to be
visible, easily legible and indelible on the explosives. themselves or, if this Ö Where
that Õ is not
possible ð or not warranted on account of the
nature of the explosive, it shall be affixed to ï , on an identification plate attached thereto or,
in the last resort, if the first two methods cannot be used, on
the packaging ð and to the accompanying
documents ï. The identification plate must be so designed as to
make its reuse impossible.

ò new

2.           The
CE marking shall be affixed before the explosive is placed on the market.

3.           The
CE marking shall be followed by the identification number of the notified body,
where that body is involved in the production control phase.

4.           The
identification number of the notified body shall be affixed by the body itself
or, under its instructions, by the manufacturer or his authorised
representative.

5.           The
CE marking and, where applicable, the identification number referred to in
paragraph 3 may be followed by a pictogram or any other mark indicating a
special risk or use.

ê 93/15/EEC (new)

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

The model to be
used for the CE marking shall be that reproduced in Annex IV.

2. It shall be
prohibited to affix on explosives any mark or inscription which may confuse
third persons as to the meaning and style of writing of the CE marking. Any
other mark may be affixed on explosives provided the è1 visibility ç and legibility of the CE marking is not
impaired.

3. Without
prejudice to the provisions of Article 8:

(a)          where
a Member State establishes that the CE marking has been unduly affixed, the
manufacturer, his agent or, failing these, the person responsible for placing
the product in question on the Community market shall be obliged to restore the
product to conformity with regard to the
provisions on marking and end the infringement under conditions imposed by the
Member States;

(b)          where
non-compliance continues, the Member State must take all appropriate measures
to restrict or prohibit the placing on the
market of the product in question or to ensure that it is withdrawn from the
market in accordance with the procedures laid down in Article 8.

ê 93/15/EEC
(adapted)

ð new

CHAPTER 5

Ö Notification
of Conformity Assessment Bodies Õ

Article
23 [Article R13 of Decision No 768/2008/EC]
 Ö Notification Õ

2. Member States shall inform
ð notify ï the Commission and the other Member States of the bodies ð authorised ï which
they have appointed to carry out the procedures for assessing the conformity
referred to above together with the specific ð third-party conformity
assessment ï tasks ð under this Directive ï which these bodies have been appointed to carry
out and the identification numbers assigned to them beforehand by the
Commission.

ò new

Article 24
[Article R14 of Decision No 768/2008/EC]
Notifying authorities

1.
Member States shall
designate a notifying authority that shall be responsible for setting up and
carrying out the necessary procedures for the assessment and notification of
conformity assessment bodies and the monitoring of notified bodies, including
compliance with Article 29.

2.
Member States may
decide that the assessment and monitoring referred to in paragraph 1 shall be
carried out by a national accreditation body within the meaning of and in
accordance with Regulation (EC) No 765/2008.

Article 25
[Article R15 of Decision No 768/2008/EC]
Requirements relating to notifying authorities

1.
A notifying authority
shall be established in such a way that no conflict of interest with conformity
assessment bodies occurs.

2.
A notifying authority
shall be organised and operated so as to safeguard the objectivity and
impartiality of its activities.

3.
A notifying authority
shall be organised in such a way that each decision relating to notification of
a conformity assessment body is taken by competent persons different from those
who carried out the assessment.

4.
A notifying authority
shall not offer or provide any activities that conformity assessment bodies
perform or consultancy services on a commercial or competitive basis.

5.
A notifying authority
shall safeguard the confidentiality of the information it obtains.

6.
A notifying authority
shall have a sufficient number of competent personnel at its disposal for the
proper performance of its tasks.

Article 26
[Article R16 of Decision No 768/2008/EC]
Information obligation on notifying authorities

Member States
shall inform the Commission of their procedures for the assessment and
notification of conformity assessment bodies and the monitoring of notified
bodies, and of any changes thereto.

The Commission
shall make that information publicly available.

ê 93/15/EEC (new)

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

The Commission
shall publish in the Official
Journal of the European Communities a list of the notified bodies and their
identification numbers and the tasks for which they have been notified. The
Commission shall ensure that this list is kept up to date.

Member States
shall apply the minimum criteria set out in Annex III for the assessment of
bodies of which the Commission is to be notified. Bodies which meet the
assessment criteria laid down by the relevant harmonized standards shall be
presumed to satisfy the relevant minimum criteria.

A Member State which
è1 has ç notified the Commission of a given body shall withdraw the notification if it discovers that
that body no longer meets the criteria referred to in the second subparagraph.
It shall immediately inform the other Member States and the Commission
accordingly.

ê 93/15/EEC
(adapted)

ANNEX III

MINIMUM CRITERIA TO BE TAKEN INTO ACCOUNT BY
MEMBER STATES FOR THE NOTIFICATION OF BODIES

Article
27 [Article R17 of Decision No 768/2008/EC]
 Ö Requirements
relating to notified bodies Õ

ò new

1.
For the purposes of
notification, a conformity assessment body shall meet the requirements laid
down in paragraphs 2 to 11.

2.
A conformity
assessment body shall be established under national law and have legal
personality.

3.
A conformity
assessment body shall be a third-party body independent of the organisation or
the explosive it assesses.

A body belonging to a
business association or professional federation representing undertakings
involved in the design, manufacturing, provision, assembly, use or maintenance
of explosives, may, on condition that its independence and the absence of any
conflict of interest are demonstrated, be considered such a body.

ê 93/15/EEC
(adapted)

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

ð new

41.         TheÖ A
conformity assessment Õ body, its Ö top level
management Õ director
and the Ö personnel Õ staff
responsible for carrying out the Ö conformity
assessment tasks Õ verification tests
shall not be the designer, manufacturer, supplier, or
installer ð , purchaser, owner, user or
maintainer ï of explosives which they inspect, nor the authoriszed representative
of any of these
Ö those Õ parties. ð This shall not preclude the use of
explosives that are necessary for the operations of the conformity assessment
body or the use of such products for personal purposes. ï

TheyÖ A
conformity assessment body, its top level management and the personnel
responsible for carrying out the conformity assessment tasks Õ shall not become either
Ö directly Õ involved directly or as authorized
representatives in the design, ð manufacture or ï construction, è1 marketing ç ð , installation, use ï or maintenance of Ö those Õ such explosives
ð or represent the parties engaged in
those activities ï. This does not preclude the possibility of
exchanges of technical information between the manufacturer and the body.
ð 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. ï

ð 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. ï

52.         The body Ö Conformity
assessment bodies Õ and Ö their
personnel Õ its staff
shall carry out the verification
tests Ö conformity
assessment activities Õ with the
highest degree of professional integrity and Ö requisite Õ technical
competence Ö in the
specific field Õ and shall be
free from all pressures and inducements, è1 particularly financial, which might influence
their judgement ç or the results
of Ö their
conformity assessment activities Õ the inspection,
especially Ö as
regards Õ from
persons or groups of persons with an interest in the result Ö results Õ of Ö those
activities Õ verifications.

ò new

6.           A
conformity assessment body shall be capable of carrying out all the conformity
assessment tasks assigned to it by Article 19 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.

At all times and for
each conformity assessment procedure and each kind or category of explosives in
relation to which it has been notified, a conformity assessment body shall have
at its disposal the necessary:

(a)
personnel with
technical knowledge and sufficient and appropriate experience to perform the
conformity assessment tasks;

(b)
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;

(c)
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.

ê 93/15/EEC
(adapted)

è1 Corrigendum, OJ L 79, 7.4.1995,
p. 34

ð new

3.Ö It Õ The body
shall have at è1 its ç disposal
the Ö means Õ necessary staff and possess the
necessary facilities to enable it to perform properly
the administrative
and technical Ö and
administrative Õ tasks
connected with Ö the
conformity assessment activities in an appropriate manner Õ verification; it
Ö and Õ shall also
have access to the
Ö all
necessary Õ equipment Ö or
facilities Õ required for special
verification.

74.         The Ö personnel Õ staff
responsible for inspection
Ö conformity
assessment activities Õ shall have Ö the
following Õ:

(a)     sound technical and professional Ö vocational Õ training ð covering all the conformity assessment
activities in relation to which the conformity assessment body has been
notified; ï,

(b)     satisfactory knowledge of the è1 requirements of the tests Ö assessments Õ they carry out
and adequate ç Ö authority
to carry out those assessments; Õ experience of such tests,

ò new

(c)     appropriate
knowledge and understanding of the essential safety requirements set out in
Annex I, of the applicable harmonised standards and of the relevant provisions
of Union harmonisation legislation and national legislation;

ê 93/15/EEC
(adapted)

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

ð new

(d)     the ability to draw up the certificates, records and reports Ö demonstrating
that assessments have been carried out Õrequired to authenticate
the performance of the tests.

85.         The
impartiality of inspection
staff Ö the
conformity assessment bodies, their top level management and of the assessment
personnel Õ shall be
guaranteed.

Their
remuneration Ö of the
top level management and assessment personnel of a conformity assessment
body Õ shall not
depend on the number of tests Ö assessments Õ carried out or
on the results of Ö those
assessments Õsuch tests.

96.         The body Ö Conformity
assessment bodies Õ shall take out
civil
liability insurance unless its liability is è1 assumed ç by the State
in accordance with national law, or the Member State itself is directly
responsible for the Ö conformity
assessment Õ tests.

107.       The Ö personnel Õ staff
of the
Ö a
conformity assessment Õ body shall be bound to
observe professional secrecy with regard to all information Ö obtained Õ gained
in carrying out Ö their Õ its
tasks (except è1 (vis-à-vis) ç) the competent
administrative authorities of the State in which its activities are carried
out) under Ö Annex II Õ this Directive
or any provision of national law giving effect to it ð , except in relation to the
competent authorities of the Member State in which its activities are carried
out. Proprietary rights shall be protected ï.

ò new

11.         Conformity
assessment bodies shall participate in, or ensure that their assessment
personnel are informed of the relevant standardisation activities and the
activities of the notified body coordination group established under the
relevant Union harmonisation legislation and apply as general guidance the
administrative decisions and documents produced as a result of the work of that
group.

Article 28
[Article R18 of Decision No 768/2008/EC]
Presumption of conformity

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 Article 27 in so
far as the applicable harmonised standards cover those requirements.

Article 29
[Article R20 of Decision No 768/2008/EC]
Subsidiaries of and subcontracting by notified bodies

1.
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 Article 27 and shall inform the
notifying authority accordingly.

2.
Notified bodies shall
take full responsibility for the tasks performed by subcontractors or
subsidiaries wherever these are established.

3.
Activities may be
subcontracted or carried out by a subsidiary only with the agreement of the
client.

4.
Notified bodies shall
keep at the disposal of the notifying authority the relevant documents
concerning the assessment of the qualifications of the subcontractor or the
subsidiary and the work carried out by them under Annex II.

Article 30
[Article R22 of Decision No 768/2008/EC]
Application for notification

1.
A conformity
assessment body shall submit an application for notification to the notifying
authority of the Member State in which it is established.

2.
That application shall
be accompanied by a description of the conformity assessment activities, the
conformity assessment module or modules and the explosive or explosives for
which that body claims to be competent, as well as by an accreditation
certificate, where one exists, issued by a national accreditation body
attesting that the conformity assessment body fulfils the requirements laid
down in Article 27.

3.
Where the conformity
assessment body concerned cannot provide an accreditation certificate, it shall
provide the notifying authority with all the documentary evidence necessary for
the verification, recognition and regular monitoring of its compliance with the
requirements laid down in Article 27.

Article 31
[Article R23 of Decision No 768/2008/EC]
Notification procedure

1.
Notifying authorities
may notify only conformity assessment bodies which have satisfied the requirements
laid down in Article 27.

2.
They shall notify the
Commission and the other Member States using the electronic notification tool
developed and managed by the Commission.

3.
The notification shall
include full details of the conformity assessment activities, the conformity
assessment module or modules and explosive or explosives concerned and the
relevant attestation of competence.

4.
Where a notification
is not based on an accreditation certificate as referred to in Article 30(2),
the notifying authority shall provide the Commission and the other Member
States with documentary evidence which attests to the conformity assessment
body's competence and the arrangements in place to ensure that that body will
be monitored regularly and will continue to satisfy the requirements laid down
in Article 27.

5.
The body concerned may
perform the activities of a notified body only where no objections are raised
by the Commission or the other Member States within two weeks of a notification
where an accreditation certificate is used or within two months of a
notification where accreditation is not used.

Only such a body
shall be considered a notified body for the purposes of this Directive.

6.
The Commission and the
other Member States shall be notified of any subsequent relevant changes to the
notification.

Article 32
[Article R24 of Decision No 768/2008/EC]
Identification numbers and lists of notified bodies

1.
The Commission shall
assign an identification number to a notified body.

It shall assign a
single such number even where the body is notified under several Union acts.

2.
The Commission shall
make publicly available the list of the bodies notified under this Directive,
including the identification numbers that have been allocated to them and the
activities for which they have been notified.

The Commission shall
ensure that that list is kept up to date.

Article 33
[Article R25 of Decision No 768/2008/EC]
Changes to notifications

1.
Where a notifying
authority has ascertained or has been informed that a notified body no longer
meets the requirements laid down in Article 27 or that it is failing to fulfil
its obligations, the notifying authority 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 Commission and the other Member States accordingly.

2.
In the event of
restriction, suspension or withdrawal of notification, or where the notified
body has ceased its activity, the notifying Member State shall take appropriate
steps to ensure that the files of that body are either processed by another
notified body or kept available for the responsible notifying and market
surveillance authorities at their request.

Article 34
[Article R26 of Decision No 768/2008/EC]
Challenge of the competence of notified bodies

1.
The Commission shall
investigate all cases where it doubts, or doubt is brought to its attention regarding,
the competence of a notified body or the continued fulfilment by a notified
body of the requirements and responsibilities to which it is subject.

2.
The notifying Member
State 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.

3.
The Commission shall
ensure that all sensitive information obtained in the course of its
investigations is treated confidentially.

4.
Where the Commission
ascertains that a notified body does not meet or no longer meets the
requirements for its notification, it shall inform the notifying Member State
accordingly and request it to take the necessary corrective measures, including
de-notification if necessary.

Article 35
[Article R27 of Decision No 768/2008/EC]
Operational obligations of notified bodies

1.
Notified bodies shall
carry out conformity assessments in accordance with the conformity assessment procedures
provided for in Annex 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 product
technology in question and the mass or serial nature of the production process.

In doing so they
shall nevertheless respect the degree of rigour and the level of protection
required for the compliance of the explosive with this Directive.

3.
Where a notified body
finds that the essential safety requirements set out in Annex I or
corresponding harmonised standards or technical specifications have not been
met by a manufacturer, it shall require that manufacturer to take appropriate
corrective measures and shall not issue a conformity certificate.

4.
Where, in the course
of the monitoring of conformity following the issue of a certificate, a
notified body finds that an explosive no longer complies, it shall require the
manufacturer to take appropriate corrective measures and shall suspend or
withdraw the certificate if necessary.

5.
Where corrective
measures are not taken or do not have the required effect, the notified body
shall restrict, suspend or withdraw any certificates, as appropriate.

Article 36
Appeal against decisions of notified bodies

Member States
shall ensure that an appeal procedure against decisions of the notified bodies
is available.

Article 37
[Article R28 of Decision No 768/2008/EC]
Information obligation on notified bodies

1.
Notified bodies shall
inform the notifying authority of the following:

(a)
 any refusal,
restriction, suspension or withdrawal of a certificate;

(b)
any circumstances
affecting the scope of and 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.

2.
Notified bodies shall
provide the other bodies notified under this Directive carrying out similar
conformity assessment activities covering the same products with relevant
information on issues relating to negative and, on request, positive conformity
assessment results.

Article 38
[Article R29 of Decision No 768/2008/EC]
Exchange of experience

The Commission
shall provide for the organisation of exchange of experience between the Member
States' national authorities responsible for notification policy.

Article 39
[Article R30 of Decision EC 768/2008]
Coordination of notified bodies

The Commission
shall ensure that appropriate coordination and cooperation between bodies
notified under this Directive are put in place and properly operated in the
form of a sectoral group of notified bodies.

Member States
shall ensure that the bodies notified by them participate in the work of that
group, directly or by means of designated representatives.

CHAPTER 6

Union market surveillance, control
of products entering the Union market and Safeguard procedures

Article 40
Union market surveillance and control of products entering the Union market

Article 15(3) and
Articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to explosives.

ê 93/15/EEC
(adapted)

Article 418
[Article R31 of Decision No 768/2008/EC]
 Ö Procedure
for dealing with explosives presenting a risk at national level Õ

ê 93/15/EEC

1.
Where a Member State establishes that an explosive
bearing CE conformity marking and being used for its intended purpose may
compromise safety, it shall take all interim measures necessary to withdraw the
explosive from the market or prohibit its being placed on the market or its freedom of movement.

The Member State shall immediately inform the
Commission of such measures, indicating the
reasons for its measures and, in particular, whether non-conformity is the
result of:

–
non-compliance
with essential requirements,

–
incorrect
application of standards, or

–
a shortcoming in
the standards.

ò new

1.           Where
the market surveillance authorities of one Member State have taken action
pursuant to Article 20 of Regulation (EC) No 765/2008, or where they have
sufficient reason to believe that an explosive presents a risk to the health or
safety of persons or to public security, they shall carry out an evaluation in
relation to the explosive concerned covering all the requirements laid down in
this Directive. The relevant economic operators shall cooperate as necessary
with the market surveillance authorities.

2.           Where,
in the course of that evaluation, the market surveillance authorities find that
the explosive does not comply with the requirements laid down in this Directive,
they shall without delay require the relevant economic operator to take all
appropriate corrective action to bring the explosive into compliance with those
requirements, to withdraw the explosive from the market, or to recall it within
a reasonable period, commensurate with the nature of the risk, as they may
prescribe.

The market
surveillance authorities shall inform the relevant notified body accordingly.

Article 21 of
Regulation (EC) No 765/2008 shall apply to the measures referred to in the
second subparagraph.

3.           Where
the market surveillance authorities consider that non-compliance is not
restricted to their national territory, they shall inform the 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.

4.           The
economic operator shall ensure that all appropriate corrective action is taken
in respect of all the explosives concerned that it has made available on the
market throughout the Union.

5.           Where
the relevant economic operator does not take adequate corrective action within
the period referred to in the second subparagraph of paragraph 1, the market
surveillance authorities shall take all appropriate provisional measures to
prohibit or restrict the explosive's being made available on their national
market, to withdraw the explosive from that market or to recall it.

The market
surveillance authorities shall inform the Commission and the other Member
States, without delay, of those measures.

6.           The
information referred to in paragraph 4 shall include all available details, in
particular the data necessary for the identification of the non-compliant
explosive, the origin of the explosive, the nature of the non-compliance
alleged and the risk involved, the nature and duration of the national measures
taken and the arguments put forward by the relevant economic operator. In
particular, the market surveillance authorities shall indicate whether the
non-compliance is due to either of the following:

(a)
failure of the
explosive to meet requirements relating to the health or safety of persons or
to other aspects of public interest protection laid down in this Directive;

(b)
shortcomings in the
harmonised standards referred to in Article 18 conferring a presumption of
conformity.

7.           Member
States other than the Member State initiating the procedure shall without delay
inform the Commission and the other Member States of any measures adopted and
of any additional information at their disposal relating to the non-compliance
of the explosive concerned, and, in the event of disagreement with the notified
national measure, of their objections.

8.           Where,
within 6 months of receipt of the information referred to in paragraph 4, no
objection has been raised by either a Member State or the Commission in respect
of a provisional measure taken by a Member State, that measure shall be deemed
justified.

9.           Member
States shall ensure that appropriate restrictive measures are taken in respect
of the explosive concerned without delay.

ê 93/15/EEC

2. The Commission
shall consult the parties concerned as soon as possible. Where the Commission
establishes, after consultation, that the measures are justified, it shall
immediately inform the Member State which took the initiative, as well as
the other Member States. Where the Commission establishes, after consultation,
that the measures are unjustified, it shall immediately inform the Member State
which took the decision.

In the particular
case where the measures referred to in paragraph 1 are based on a
shortcomings in the standards, the Commission shall first consult the parties
concerned and then within two months bring the matter before the Standing
Committee set up by Directive 83/189/EEC if the Member State which took the
measures intends to maintain them and initiates the procedures referred to
in Article 5.

ò new

Article 42
[Article R32 of Decision No 768/2008/EC]
 Union safeguard procedure

1.
Where, on completion
of the procedure set out in Article 41(3) and (4), objections are raised
against a measure taken by a Member State, or where the Commission considers a
national measure to be contrary to Union legislation, the Commission shall
without delay enter into consultation with the Member States and the relevant
economic operator or operators and shall evaluate the national measure. On the
basis of the results of that evaluation, the Commission shall decide whether
the national measure is justified or not.

The Commission shall
address its decision to all Member States and shall immediately communicate it
to them and the relevant economic operator or operators.

2.
If the national
measure is considered justified, all Member States shall take the measures
necessary to ensure that the non-compliant explosive is withdrawn from their
market, and shall inform the Commission accordingly. If the national measure is
considered unjustified, the Member State concerned shall withdraw the measure.

3.
Where the national
measure is considered justified and the non-compliance of the explosive is
attributed to shortcomings in the harmonised standards referred to in Article
18 of this Directive, the Commission shall apply the procedure provided for in
Article 8 of (EU) No [../..] [Standardisation Regulation].

Article 43
[Article R33 of Decision No 768/2008/EC]
Compliant explosives which present a risk to health and safety

1.
Where, having performed
an evaluation under Article 41(1), a Member State finds that although an
explosive is in compliance with this Directive, 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 explosive concerned, when placed on the market, no
longer presents that risk, to withdraw the explosive from the market or to
recall it within a reasonable period, commensurate with the nature of the risk,
as it may prescribe.

2.
The economic operator
shall ensure that corrective action is taken in respect of all the explosives
concerned that he has made available on the market throughout the Union.

3.
The Member State shall
immediately inform the Commission and the other Member States. That information
shall include all available details, in particular the data necessary for the
identification of the explosive concerned, the origin and the supply chain of
the explosive, the nature of the risk involved and the nature and duration of
the national measures taken.

4.
The Commission shall
without delay enter into consultation with the Member States and the relevant
economic operator or operators and shall evaluate the national measures taken.
On the basis of the results of that evaluation, the Commission shall decide
whether the measure is justified or not, and where necessary, propose
appropriate measures.

5.
The Commission shall
address its decision to all Member States and shall immediately communicate it
to them and the relevant economic operator or operators.

ê 93/15/EEC
(adapted)

Article 44 [Article R34 of Decision No 768/2008/EC]
 Ö Formal
non-compliance Õ

3. Where CE
conformity marking is borne by an explosive which does not comply with the
requirements, the competent Member State shall take appropriate
measures in respect of the person who affixed the marking and shall inform
the Commission and the other Member States.

ò new

1.
Without prejudice to
Article 41, where a Member State makes one of the following findings, it shall
require the relevant economic operator to put an end to the non-compliance
concerned:

(a)
the conformity marking
has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or
of Article 22 of this Directive;

(b)
the conformity marking
has not been affixed;

(c)
the EU declaration of
conformity has not been drawn up;

(d)
the EU declaration of
conformity has not been drawn up correctly;

(e)
technical
documentation is either not available or not complete.

2.
Where the
non-compliance referred to in paragraph 1 persists, the Member State concerned
shall take all appropriate measures to restrict or prohibit the explosive being
made available on the market or ensure that it is recalled or withdrawn from
the market.

CHAPTER 7

Delegated powers and Committee

Article 45
Delegated power

The Commission
shall be empowered to adopt delegated acts in accordance with Article 46
concerning the identification of pyrotechnic articles referred to in Article
1(2)(b) and of certain ammunition referred to in Article 1(1)(b) on the basis
of the United Nations recommendations on the transport of dangerous goods.

Article 46
Exercise of the delegation

1.
The power to adopt
delegated acts is conferred on the Commission subject to the conditions laid
down in this Article.

2.
The delegation of
power referred to in Article 45 shall be conferred for an indeterminate period
of time from [insert a date - the date of entry into force of this
Directive].

3.
The delegation of powers
referred to in Article 45 may be revoked at any time by the European Parliament
or by the Council. A decision of revocation shall put an end to the delegation
of the power specified in that decision. It shall take effect the day following
the publication of the decision in the Official Journal of the European
Union or at a later date specified therein. It shall not affect the
validity of any delegated acts already in force.

4.
As soon as it adopts a
delegated act, the Commission shall notify it simultaneously to the European
Parliament and to the Council.

5.
A delegated act
adopted pursuant to Article 45 shall enter into force only if no objection has
been expressed either by the European Parliament or the Council within a period
of 2 months of notification of that act to the European Parliament and the
Council or if, before the expiry of that period, the European Parliament and
the Council have both informed the Commission that they will not object. That
period shall be extended by 2 months at the initiative of the European
Parliament or the Council.

ê (EC)
219/2009 (adapted)

ð new

Article 4713
 Ö Committee
procedure Õ

1.           The Commission shall be
assisted by Ö the Õ a Ccommittee Ö on Civil
Explosives Õ. ð That committee shall be a committee
within the meaning of Regulation (EU) No 182/2011. ï

ê (EC)
219/2009

ð new

2. The committee
shall examine any matter concerning the application of this Directive.

23.         Where
reference is made to this paragraph, Articles ð 5 ï 4 and 7 of ð Regulation (EU) No 182/2011 ï Decision 1999/468/EC
shall apply, having regard to the provisions of
Article 8 thereof.

4. Where reference
is made to this paragraph, Article 5a(1) to (4) and Article 7 of
Decision 1999/468/EC shall apply, having regard to the provisions of
Article 8 thereof.

5 The Commission
shall, in accordance with the management procedure referred to in
paragraph 3, adopt implementing measures in particular to take account of
any future amendments to the United Nations recommendations.

ê 93/15/EEC
(adapted)

CHAPTER V 8

Ö Transitional
and Õ Final
Provisions

Article 4817
 Ö Penalties Õ

Each
Member States shall determine
Ö lay down
rules on Õ the
penalties Ö applicable Õ to be applied for infringement
Ö infringements Õ of the Ö national Õ provisions
adopted Ö pursuant
to Õ in implementation of
this Directive Ö and shall
take all measures necessary to ensure that they are enforced Õ. The penalties shall be
sufficient to promote compliance with those provisions.

Ö The penalties
provided for shall be effective, proportionate and dissuasive. Õ

ò new

Member States
shall notify those provisions to the Commission by [insert the date
specified in Article 50(1)] at the latest and shall notify it without delay
of any subsequent amendment affecting them.

ê 93/15/EEC
(adapted)

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

ð new

Article 4919
 Ö Transitional
provisions Õ

1. Member States shall ð not impede the making available on
the market of explosives covered by Directive 93/15/EC which are in conformity
with that Directive and which were placed on the market before [Insert date
- date referred to in the second subparagraph of Article 48(1)] ï bring
into force the provisions necessary to comply with Articles 9, 10, 11, 12, 13
and 14 before 30 September 1993.

ð Certificates of conformity issued
under Directive 93/15/EEC shall be valid under this Directive. ï

Article
50
 Ö Transposition Õ

12.         Member
States shall adopt and publish Ö , by [insert
date – 2 years after adoption] at the latest, Õ before 30 June 1994
the laws, regulations and administrative provisions necessary to comply with Ö Articles
2 (7), 2 (9)-(24), 3-10, 14 (1), 19 (1) (a) (i), 20-26, 27 (1)-(4), 27 (6)-(7),
27 (10)-(11), 28-44, 48, 49 and Annex II Õ the provisions other than
those mentioned in paragraph 1. They shall forthwith inform Ö communicate
to Õ the Commission
thereof
Ö the text
of those provisions and a correlation table between those provisions and this
Directive Õ.

They shall apply Ö those Õ these
provisions as
from Ö [day
after the date mentioned in the first subparagraph] Õ 1 January 1995.

3. When Member States adopt the provisions referred to in paragraphs 1 and 2
those provisions, Ö they Õ shall contain
a reference to this Directive or shall be accompanied by such Ö a Õ reference on
the occasion of their official publication. Ö They
shall also include a statement that references in existing laws, regulations
and administrative provisions to the Directive repealed by this Directive shall
be construed as references to this Directive. Õ The methods of making
such a reference shall be determined by the Member
States Ö shall
determine how such reference is to be made and how that statement is to be
formulated Õ.

4. However, during the period up to 31 December
2002, Member States shall allow the placing on the è1 market ç of explosives complying
with the national regulations in force in their territory before 31 December
1994.

25.         Member
States shall communicate to the Commission the Ö text of
the main Õ provisions of
national law which they adopt in the field Ö covered Õ governed
by this Directive.

ê

Article 51
Repeal

Directive 93/15/EEC as amended by the acts
listed in Annex III is repealed with effect from [day after the date set out
in the second subparagraph of Article 48(1) of this Directive].

References to Directive 93/15/EEC shall be
construed as references to this Directive and shall be read in accordance with
the correlation table in Annex IV.

Article 52
Entry into force

This Directive shall enter into force on
the twentieth day following that of its publication in the Official Journal
of the European Union.

Articles 1, 2
(1) – (6), 2 (8), 11, 12, 13, 14 (2), 15, 16, 17, 18, 19 (1) (a) (ii) – (iv),
19 (1) (b), 27 (5), 27 (8), 27 (9), 45-47 and Annexes I, III and IV shall apply
from [day after the date set out in the second subparagraph of Article 48
(1)].

ê 93/15/EEC

Article 5320

This
Directive is addressed to the Member States.

Done at [...].

For the European Parliament                       For
the Council

The
President                                                 The President

ê 93/15/EEC

ANNEX I

ESSENTIAL SAFETY REQUIREMENTS

I.
General requirements

ê 93/15/EEC (adapted)

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

1.
Each explosive must be designed, manufactured
and supplied in such a way as to present a minimal risk to the safety of human
life and health, and to prevent damage to property and the environment under
normal, foreseeable conditions, in particular as regards the safety rules and è1 standard practices until such time as
it is used. ç

ê 93/15/EEC

2.
Each explosive must attain the performance
characteristics specified by the manufacturer in order to ensure maximum safety
and reliability.

3.
Each explosive must be designed and manufactured
in such a way that when appropriate techniques are employed it can be disposed
of in a manner which minimizes effects on the environment.

II.
Special requirements

ê 93/15/EEC
(adapted)

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

1.           As a minimum, the
following information and properties,—
where appropriate ,—
è1 must be considered or tested:. çEach explosive should be
tested under realistic conditions. If this is not possible in a laboratory,
the tests should be carried out in the conditions in which the explosive is to
be used.

ê 93/15/EEC

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

(a)          è1 dDesign
and characteristic properties, including chemical composition, degree of
homogeneity ç and, where
appropriate, dimensions and grain size distribution;.

(b)          tThe
physical and chemical stability of the explosive in all environmental
conditions to which it may be exposed;.

(c)          sSensitiveness
to impact and friction;.

(d)          cCompatibility
of all components as regards their physical and chemical stability;.

(e)          tThe
chemical purity of the explosive;.

(f)           Resistance of the explosive
against influence of water where it is intended to be used in humid or wet
conditions and where its safety or reliability may be adversely affected by
water;.

(g)          rResistance
to low and high temperatures, where the explosive is intended to be kept or
used at such temperatures and its safety or reliability may be adversely
affected by cooling or heating of a component or of the explosive as a whole;.

ê 93/15/EEC (adapted)

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

(h)          tThe
suitability of the explosive for use in hazardous environments è1 (e.g. firedamp atmospheres, hot masses, etc.) ç if it is
intended to be used under such conditions;.

ê 93/15/EEC

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

(i)           sSafety
features intended to prevent untimely or inadvertent initiation or ignition;.

(j)           tThe
correct loading and functioning of the explosive when used for its intended
purpose;.

(k)          sSuitable
instructions and, where necessary, markings in respect of safe handling,
storage, use and disposal in the official language or languages of the
recipient Member State;.

(l)           è1 tThe
ability of the explosive, its wrapping or ç other
components to withstand deterioration during storage until the «use by» date
specified by the manufacturer;.

(m)         sSpecification
of all devices and accessories needed for reliable and safe functioning of the
explosive.

ê 93/15/EEC
(adapted)

2.           Ö Each
explosive shall be tested under realistic conditions. If this is not possible
in a laboratory, the tests shall be carried out in the conditions in which the
explosive is to be used. Õ

32.         The variousÖ Requirements
for the Õ groups of
explosives must at
least also comply with the following requirements:

3.1A.      Blasting
explosives Ö shall
also comply with the following requirements: Õ

ê 93/15/EEC

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

(a)          tThe
proposed method of initiation must ensure safe, reliable and complete
detonation or deflagration as appropriate, of the blasting explosive. In the
particular case of black powder, it is the capacity as regards deflagration
which shall be checked;.

(b)          bBlasting
explosives in cartridge form must transmit the detonation safely and reliably
from one end of the train of cartridges to the other;.

(c)          è1 tThe
fumes produced by blasting explosives intended for underground use may contain
carbon monoxide, nitrous gases, other gases, vapours or airborne ç solid residues
only in quantities which do not impair health under normal operating
conditions.

ê 93/15/EEC (adapted)

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

3.2B.      è1 Detonating cords, safety fuses, other fuses and
shock tubes ç Ö shall
also comply with the following requirements: Õ

ê 93/15/EEC

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

(a)          tThe
covering of detonating cords, safety fuses è1 and other fuses must ç be of adequate
mechanical strength and adequately protect the explosive filling when exposed
to normal mechanical stress;.

(b)          tThe
parameters for the burning times of safety fuses must be indicated and must be
reliably met;.

(c)          dDetonating
cords must be capable of being reliably initiated, be of sufficient initiation
capability and comply with requirements as regards storage even in particular
climatic conditions.

ê 93/15/EEC
(adapted)

3.3C.      Detonators
(including delay detonators) and relays Ö shall
also comply with the following requirements: Õ

ê 93/15/EEC

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

(a)          dDetonators
must reliably initiate the detonation of the blasting explosives which are
intended to be used with them under all foreseeable conditions of use;.

(b)          è1 dDelay
connectors for detonating cords must be reliably initiated;. ç

(c)          tThe
initiation capability must not be adversely affected by humidity;.

(d)          tThe
delay times of delay detonators must be sufficiently uniform to ensure that the
probability of overlapping of the delay times of adjacent time steps is
insignificant;.

ê 93/15/EEC
(adapted)

(e)          tThe
electrical characteristics of electric detonators must be indicated on the
packaging (e.g. no-fire current, resistance, etc.);.

ê 93/15/EEC

(f)           tThe
wires of electric detonators must be of sufficient insulation and mechanical
strength including the solidity of the link to the detonator, taking account of
their intended use.

ê 93/15/EEC
(adapted)

3.4D.      Propellants
and rocket propellants Ö shall
also comply with the following requirements: Õ

ê 93/15/EEC

(a)          tThese
materials must not detonate when used for their intended purpose;.

(b)          pPropellants
where necessary (e.g. those based on nitrocellulose) must be stabilized against
decomposition;.

(c)          sSolid
rocket propellants, when in compressed or cast form, must not contain any
unintentional fissures or gas bubbles which dangerously affect their
functioning.

ê 93/15/EEC
(adapted)

ð new

ANNEX II

Ö CONFORMITY
ASSESSMENT PROCEDURES Õ

1.
MODULE B:

EC Ö EU Õ type –examination

1. This module describes that part
of the procedure by which a notified body ascertains and attests that an
example, representative of the production envisaged, meets the relevant
provisions of the Directive.

ò new

1. EU type
examination is the part of a conformity assessment procedure in which a
notified body examines the technical design of an explosive and verifies and
attests that the technical design of the explosive meets the requirements of this
Directive that apply to it.

2. EU type
examination shall be carried out as an examination of a specimen,
representative of the production envisaged, of the complete product (production
type).

ê 93/15/EEC
(adapted)

23. The Ö manufacturer
shall lodge Õ application for EC
type-examination is lodged by the manufacturer or his authorized
representative established within the Community Ö an
application for EU type examination Õ with a Ö single Õ notified body
of his choice.

The application must Ö shall Õ include:

(a)          the name and address of the manufacturer and, if the
application is lodged by the authoriszed
representative, Ö his Õ the
name and address Ö as
well Õ;in addition,

ê 93/15/EEC

(b)          a written declaration that the same application has not
been lodged with any other notified body;,

ê 93/15/EEC
(adapted)

ð new

(c)          the technical Ö documentation Õ documents, as described
in Section 3.The applicant must
place at the disposal of the notified body an example representative of the
production envisaged, hereinafter called «type». The notified body may request
further examples if needed for carrying out the test programme.3.
The technical Ö documentation Õ documents must enable
Ö shall
make it possible to assess Õ the Ö explosive's Õ conformity of the appliance
with the Ö applicable Õ requirements
of the
Ö this Õ Directive Ö and shall
include an adequate analysis and assessment of the risk(s) Õ to be assessed. They must
ð The technical documentation shall
specify the applicable requirements and cover ï, as far as is relevant for Ö the Õ such
assessment, cover
the design, manufacture and operation of the Ö explosive. Õ appliance and
Ö The
technical documentation shall Õ contain Ö wherever
applicable, at least the following elements Õ as far as is relevant for
assessment:

(i)      a general type-description Ö of the
explosive Õ;,

(ii)     conceptual design and manufacturing drawings and Ö schemes Õ diagrams
of Ö e.g. Õ components,
sub-assemblies, circuits;,
etc.,

(iii)     descriptions and explanations necessary for the understanding
of the Ö those Õ drawings and Ö schemes Õ diagrams
and the operation of the Ö explosive Õ;product,

(iv)    a list of the Ö harmonised Õ standards Ö and/or other
relevant technical specifications the references of which have been published
in the Official Journal of the European Union Õ referred to in Article 4,
applied in full or in part, and descriptions of the solutions adopted to meet
the essential requirements of the Ö this Õ Directive where
the Ö those harmonised Õ standards referred to in Article 5
have not been applied.,
ð In the event of partly applied
harmonised standards, the technical documentation shall specify the parts which
have been applied. ï

ê 93/15/EEC

(v)     results of design calculations made, examinations carried out,
etc.;,

(vi)    test reports;.

ò new

(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 and/or technical
specifications have not been applied in full. The supporting evidence shall
include, where necessary, the results of tests carried out by the appropriate
laboratory of the manufacturer, or by another testing laboratory on his behalf
and under his responsibility.

ê 93/15/EEC
(adapted)

ð new

4.           The notified body Ö shall Õ must:

Ö For the
explosive: Õ

4.1.        examine the technical Ö documentation Õ ð and supporting evidence to assess
the adequacy of the technical design of the explosive. ïdocuments,

Ö For the
specimen(s): Õ

4.2.        verify that the Ö specimen(s)
have Õ type has
been manufactured in conformity with Ö the
technical documentation Õ those documents
and identify the elements which have been designed in accordance with the Ö applicable
provisions of the Õ relevant provisions of the
Ö harmonised Õ standards Ö and/or
technical specifications, as well as the elements Õ referred to in Article 4
as well as the components which have been designed without
applying the relevant provisions of those standards;

4.3.4.2.  perform or have performed
the Ö carry
out Õ appropriate
examinations and necessary
testsÖ , or have
them carried out, Õ to check
whether, where the Ö manufacturer
has chosen to apply Õ standards referred to in
Article 4 have not been applied, the solutions Ö in the
relevant harmonised standards and/or technical specifications, these have been
applied correctly Õ adopted by the
manufacturer meet the essential requirements of the Directive;

4.4.4.3.  perform or have performed
the Ö carry
out Õ appropriate
examinations and necessary
tests Ö , or have
them carried out, Õ to check
whether, where the Ö solutions
in Õ manufacturer has chosen
to apply the relevant Ö harmonised Õ standards,
these Ö and/or
technical specifications Õ have Ö not Õ actually
been applied ð , the solutions adopted by the
manufacturer meet the corresponding essential safety requirements of this
Directive ï;

4.5.4.4.  agree with
the applicant
Ö manufacturer
on a Õ the
location where the examinations and necessary tests Ö will Õ are to
be carried out.

ò new

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.

ê 93/15/EEC
(adapted)

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

ð new

65.         Where
the type meets the Ö requirements Õ relevant provisions
of this Directive, the notified body Ö shall Õ issues
an EC
Ö EU Õ type -examination
certificate to the Ö manufacturer Õ applicant.
The certificate Ö shall contain Õ contains
the name and è1 address ç of the
manufacturer, the conclusions of
the examination, Ö the
conditions (if any) for its validity Õ and Ö the Õ necessary data
for identification of the approved type. ð The certificate may have one or more
annexes attached. ï

ò new

The certificate and
its annexes shall contain all relevant information to allow the conformity of
manufactured products with the examined type to be evaluated and to allow for
in-service control.

Where the type does
not satisfy the applicable requirements of this Directive, the notified body
shall refuse to issue an EU type examination certificate and shall inform the
applicant accordingly, giving detailed reasons for its refusal.

ê 93/15/EEC

A list of the
relevant parts of the technical documents is annexed to the certificate and
a copy kept by the notified body.

If the
manufacturer or his authorized representative established in the Community is
refused a type certificate, the notified body must provide detailed reasons for
such refusal.

Provision must be
made for an appeals procedure.

ò new

7.           The
notified body shall keep itself appraised 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 this Directive, and shall
determine whether such changes require further investigation. If so, the
notified body shall inform the manufacturer accordingly.

ê 93/15/EEC (adapted)

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

6.The Ö manufacturer
shall inform Õ applicant
informs
the notified body that holds the technical documents Ö documentation
relating to Õ concerning
the EC
Ö EU Õ type -examination
certificate of all è1 modifications ç to the
approved Ö type Õ appliance
which must receive additional approval where such
changes Ö that Õ may affect the
conformity Ö of the
explosive Õ with the
essential Ö safety Õ requirements Ö of this
Directive Õ or the prescribed
conditions for Ö validity
of the certificate Õ use of the product.
This
Ö Such
modifications shall require Õ additional
approval is given
in the form of an addition to the original EC Ö EU Õ type -examination
certificate.

ò new

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 certificates and/or any additions thereto
refused, suspended or otherwise restricted.

ê 93/15/EEC
(adapted)

ð new

7. Each notified body Ö shall
inform Õ must communicate to
the other notified bodies the relevant information concerning the Ö EU Õ EC type
-examination
certificates and Ö /or
any Õ additions ð thereto which it has refused, ï issued
and withdrawn ð , suspended or otherwise restricted,
and, upon request, concerning the certificates and/or additions thereto which
it has issued ï.

8. The ð Commission, the Member States and
the ï other notified bodies may Ö , on
request, obtain a copy Õ receive
copies
of the EC
Ö EU Õ type -examination
certificates and/or their
additions Ö thereto Õ. The Annexes to the certificates must be kept at
the disposal of the other notified bodies. ð On request, the Commission and the
Member States may obtain a copy of the technical documentation and the results
of the examinations carried out by the notified body. The notified body shall
keep a copy of the EU type examination certificate, its annexes and additions,
as well as the technical file including the documentation submitted by the
manufacturer, until the expiry of the validity of the certificate. ï

9.           The manufacturer or his authorized
representative established within the Community must Ö shall Õ keep with the technical
documents Ö a copy Õ copies
of EC
Ö EU Õ type -examination
certificates and their Ö its
annexes and Õ additions Ö together
with the technical documentation at the disposal of the national
authorities Õ for a period of at least
10 years after the ð explosive has been placed on the
market ï last date of manufacture of the product concerned.

ò new

10.         The
manufacturer's authorised representative may lodge the application referred to
in point 3 and fulfil the obligations set out in points 7 and 9, provided that
they are specified in the mandate.

ê 93/15/EEC

ð new

Where neither the
manufacturer nor his authorized representative is established within the
Community, the obligation to keep the technical documents available is the
responsibility of the person who places the product on the Community market.

2.
MODULE C 2:

Conformity to type ð based on internal production
control plus supervised product checks at random intervals ï

ê 93/15/EEC
(adapted)

ð new

1.           This module describes that part of the
ð Conformity to type based on internal
production control plus supervised product checks at random intervals is the
part of a conformity assessment ï procedure whereby the manufacturer or his authorized
representative established within the Community ð fulfils the obligations laid down in
points 2, 3 and 4, and ï ensures and declares Ö on his
sole responsibility Õ that the
explosives concerned are in conformity with the type as described in the EC Ö EU Õ type -examination
certificate and satisfy the requirements of this Directive that apply to them. The manufacturer must affix the CE mark to each
explosive and draw up a written declaration of conformity.

2.           Ö Manufacturing Õ

The manufacturer Ö shall Õ must
take all measures necessary Ö so Õ to ensure
that the manufacturing process Ö and its
monitoring Õ Ö ensure Õ assures the
conformity of the manufactured products with the type as
described in the EC
Ö EU Õ type -examination
certificate Ö and Õ with the essential safety
requirements of the
Ö this Õ Directive Ö that
apply to them Õ.

ò new

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 explosive, taking into account, inter alia,
the technological complexity of the explosives and the quantity of production.
An adequate sample of the final products, taken on site by the notified body
before the placing on the market, shall be examined and appropriate tests as
identified by the relevant parts of the harmonised standards and/or technical
specifications, or equivalent tests, shall be carried out to check the
conformity of the explosive with the type described in the EU type examination
certificate and with the relevant requirements of this Directive. 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 explosive performs within acceptable limits, with
a view to ensuring conformity of the explosive.

Where the tests are
carried out by notified body, the manufacturer shall, under the responsibility
of the notified body, affix the notified body's identification number during
the manufacturing process.

4.           Conformity
marking and declaration of conformity

4.1.        The
manufacturer shall affix the required conformity marking set out in this
Directive to each individual product that is in conformity with the type
described in the EU type examination certificate and satisfies the applicable
requirements of this Directive.

ê 93/15/EEC
(adapted)

ð new

4.2.3.     The
manufacturer or his
authorized representative must ð shall draw up a written declaration
of conformity for the explosive and ï keep a
copy of the declaration of conformity ð it at the disposal of the national
authorities ï for a
period of at least 10 years after the ð explosive has been placed on the
market. The declaration of conformity shall identify the explosive for which it
has been drawn up ï last date of manufacture of the product concerned.

ò new

5.           Authorised
representative

The manufacturer's
obligations set out in point 4 may be fulfilled by his authorised
representative, on his behalf and under his responsibility, provided that they
are specified in the mandate.

ê 93/15/EEC (new)

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

Where neither the
manufacturer nor his is established within the Community, the obligation to
keep the technical documents available is the responsibility of the person who
places the product on the Community market.

4. A notified
body chosen by the manufacturer must perform or have performed examinations of
the product at random intervals. A suitable sample of the finished products,
taken on the spot by the notified body, is examined è1 and appropriate
tests, ç defined in the applicable standard or
standards referred to in Article 4 or equivalent tests are carried out to check
the conformity of the product with the requirements of the corresponding
Directive. In the event of one or more samples of the products examined not conforming, the notified body must take the
appropriate measures.

Under the
responsibility of the notified body the manufacturer shall affix the
identification symbol of that body during the manufacturing process.

3.
MODULE D:

ê 93/15/EEC
(adapted)

ð new

Ö Conformity
to type based on Õ Production
quality assurance Ö of the
production process Õ

1.           This module describes the ð Conformity to type based on quality
assurance of the production process is the part of a conformity
assessment ï procedure whereby the manufacturer Ö fulfils Õ who satisfies
the obligations Ö laid down
in points 2 and 5, and Õ of Section 2
ensures and declares Ö on his
sole responsibility Õ that the
explosives concerned are in conformity with the type as described in the EC Ö EU Õ type -examination
certificate and satisfy the requirements of this Directive Ö that
apply to them Õ. The manufacturer affixes the CE mark to each
explosive and draws up a written declaration of conformity. The CE mark is
accompanied by the identification symbol of the notified body responsible
for the checks referred to in Section 4.

2.           Ö Manufacturing Õ

The manufacturer must Ö shall Õ operate an
approved quality system for production, final product inspection and testing Ö of the
explosives concerned Õ as specified
in point Section
3, Ö and shall
be Õ .
He is subject to Ö surveillance
as specified in Õ the checks referred to
in point Section
4.

3.           Quality system

3.1.        The manufacturer Ö shall
lodge Õ lodges
an application for assessment of his quality system with Ö the Õ a
notified body of his choice, for the explosives concerned.

The application must Ö shall Õ include:

ò new

(a)
the name and address
of the manufacturer and, if the application is lodged by the authorised
representative, his name and address as well;

(b)
a written declaration
that the same application has not been lodged with any other notified body;

ê 93/15/EEC
(adapted)

(c)     all relevant information for the explosiveÖ product Õ category
envisaged;,

(d)     the documents
Ö documentation Õ concerning the
quality system;,

(e)     the technical documents Ö documentation
of Õ pertaining to
the approved type and a copy of the EC Ö EU Õ type-examination
certificate.

3.2.        The quality system must Ö shall Õ ensure Ö that
the Õ conformity of
explosives Ö are in
conformity Õ with the type as
described in the EC
Ö EU Õ type -examination
certificate and Ö comply Õ with the
requirements of this Directive that apply to them.

All the elements, requirements and provisions
adopted by the manufacturer must Ö shall Õ be documented
in a systematic and orderly manner in the form of written policies, procedures
and instructions. The quality system documents must Ö documentation
shall Õ permit a
consistent interpretation of the quality programmes, plans, manuals and quality
records.

It must Ö shall, in
particular, Õ contain in particular
an adequate description of:

(a)     the quality objectives and the organiszational
structure, responsibilities and powers of the management with regard to the Ö product Õ quality of the
explosives;,

(b)     the Ö corresponding Õ manufacturing,
quality control and quality assurance techniques, processes and systematic actions
that will be used;,

ê 93/15/EEC

(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;,

ê 93/15/EEC
(adapted)

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

ð new

(d)     the quality records, such as inspection reports and test data,
calibration data, qualification reports Ö on Õ of the
personnel concerned;,
etc.,

(e)     the means of monitoring the achievement of the required Ö product Õ quality of explosive
and the effective operation of the quality system.

3.3.        The notified body must Ö shall Õ assess the
quality system to determine whether it satisfies the requirements referred to
in Ö point Õ 3.2.

It must Ö shall Õ presume
conformity with those requirements in respect of Ö the
elements of the Õ quality systems that ð comply with the corresponding
specifications of the national standard that ï implements the
relevant harmoniszed
standard Ö and/or
technical specifications Õ.

ð In addition to experience in quality
management systems, ï tThe
auditing team must
Ö shall Õ have at least
one member with experience of assessing Ö evaluation
in Õ the relevant
product Ö field and
product Õ technology Ö concerned, Õ ð and knowledge of the applicable
requirements of this Directive ï. The assessment
procedure Ö audit
shall include Õ includes
an inspection
Ö assessment Õ visit to the
manufacturer's premises. ð The auditing team shall review the
technical documentation referred to in point 3.1, fifth indent, to verify the
manufacturer's ability to identify the relevant requirements of this Directive
and to carry out the necessary examinations with a view to ensuring compliance
of the explosive with those requirements. ï

The decision is Ö shall
be Õ notified to
the manufacturer. The notification must Ö shall Õ contain the è1 conclusions ç of the examination
Ö audit Õ and the Ö reasoned Õ duly substantiated
assessment decision.

3.4.        The manufacturer must Ö shall Õ undertake to
fulfil the obligations arising out of the quality system as approved and Ö to Õ maintain it Ö so that
it remains Õ at an
adequate and efficient level.

3.5.        The manufacturer or his authorized representative must
Ö shall Õ keep the
notified body that has approved the quality system informed of any Ö intended Õ proposed
change Ö to Õ in the
quality system.

The notified body must Ö shall
evaluate Õ assess the Ö any proposed Õ changes proposed
è1 and ç decide whether
the Ö modified Õ altered
quality system will Ö continue
to Õ still
satisfy the requirements referred to in Ö point Õ 3.2 or whether
a reassessment is Ö necessary Õ required.

It must Ö shall Õ notify the
manufacturer of its decision. The notification Ö shall Õ must
contain the conclusions of the examination and the Ö reasoned Õ substantiated
assessment decision.

4.           Ö Surveillance Õ Monitoring
under the responsibility of the notified body

4.1.        The purpose of Ö surveillance Õ monitoring
is to make sure that the manufacturer duly fulfils the obligations arising out
of the approved quality system.

4.2.        The manufacturer must Ö shall,
for assessment purposes, Õ allow the
notified body access for inspection purposes to the Ö manufacture Õ manufacturing,
inspection, testing and storage Ö sites Õ premises
and Ö shall Õ provide it
with all necessary information, in particular:

(a)     the quality system documents Ö documentation Õ ;,

(b)     the quality records, such as inspection reports and test data,
calibration data, qualification reports Ö on Õ of the
personnel concerned;,
etc.

4.3.        The notified body must Ö shall Õ periodically
carry out Ö periodic Õ audits to make
sure that the manufacturer maintains and applies the quality system and provides an audit report to
the manufacturer Ö with an
audit report Õ

4.4         Ö In
addition, Õ Additionally
the notified body may pay Ö unexpected Õ unannounced
visits to the manufacturer. During such visits the notified body may Ö , if
necessary, Õ carry out Ö product Õ tests, or have them carried out, Ö in
order Õ to verify that
the quality system is functioning correctly.;
if necessary,
Tthe notified body must Ö shall Õ provide the
manufacturer with a visit report and, if a test has Ö tests
have been carried out Õ taken place,
with a test report.

ò new

5.           Conformity
marking and declaration of conformity

5.1.        The
manufacturer shall affix the required conformity marking set out in this
Directive, and, under the responsibility of the notified body referred to in
point 3.1, the latter's identification number to each individual product that
is in conformity with the type described in the EU type examination certificate
and satisfies the applicable requirements of this Directive.

5.2.        The
manufacturer shall draw up a written declaration of conformity for each product
model and keep it at the disposal of the national authorities for 10 years
after the explosive has been placed on the market. The declaration of
conformity shall identify the explosive for which it has been drawn up.

A copy of the
declaration of conformity shall be made available to the relevant authorities
upon request.

ê 93/15/EEC
(adapted)

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

ð new

65.         The
manufacturer must
Ö shall Õ , for a period
of at least 10 years after the ð explosive has been placed on the
market ï last date of manufacture of the product,
keep at the disposal of the national authorities:

(a)     the document
Ö documentation Õ referred to in
the
second indent of point
3.1;,

(b)     the Ö change Õ updating
referred to in point 3.5, Ö as
approved Õ second
paragraph of 3.4;,

(c)     the decisions and reports è1 from ç Ö of Õ the notified
body which are
referred to in the final paragraph of 3.4, points 3.5, and
in 4.3 and 4.4.

ò new

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.

ê 93/15/EEC
(adapted)

ð new

6. Each notified body must give Ö shall
inform Õ the other
notified bodies the
relevant information concerning the Ö of Õ quality system
approvals Ö which it
has Õ issued and
ð refused, suspended, ï withdrawn ð or otherwise restricted, and, upon
request, of quality system approvals which it has issued ï .

ò new

8.           Authorised
representative

The manufacturer's
obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his
authorised representative, on his behalf and under his responsibility, provided
that they are specified in the mandate.

ê 93/15/EEC
(adapted)

ð new

4.
MODULE E:

Ö Conformity
to type based on Õ pProduct quality
assurance

1.           This module describes the ð Conformity to type based on product
quality assurance is that part of a conformity assessment ï procedure whereby the manufacturer Ö fulfils Õ who satisfies
the obligations Ö laid down
in points 2 and 5, and Õ of Section 2
ensures and declares Ö on his
sole responsibility Õ that the
explosives Ö concerned Õ are in
conformity with the type as described in the EC Ö EU Õ type -examination
certificate ð and satisfy the requirements of this
Directive that apply to them. ï The manufacturer must affix the CE mark to each
explosive and draw up a written declaration of conformity. The CE mark must be
accompanied by the identification symbol of the notified body responsible for
the checks referred to in Section 4.

2.           Ö Manufacturing Õ

The manufacturer must Ö shall Õ operate an
approved quality system for final explosive Ö product Õ inspection and
testing Ö of the
explosives concerned Õ as specified
in point Section
3.
He must Ö and
shall Õ be subject to Ö surveillance Õ the checks
Ö as
specified Õ referred to
in point Section
4.

3.           Quality system

3.1.        The manufacturer Ö shall lodge Õ lodges
an application Ö for
assessment of his quality system Õ with a Ö the Õ notified body
of his choice, for the assessment of the
quality system for Ö the Õ his
explosives Ö concerned Õ.

The application must Ö shall Õ include:

ò new

(a)
the name and address
of the manufacturer and, if the application is lodged by the authorised
representative, his name and address as well;

(b)
a written declaration
that the same application has not been lodged with any other notified body;

ê 93/15/EEC
(adapted)

ð new

(c)     all relevant information for the explosive Ö product Õ category
envisaged;,

(d)     the quality
system's documentation Ö concerning
the quality system Õ;,

(e)     the technical Ö documentation Õ documents Ö of Õ pertaining to
the approved type and a copy of the EC Ö EU Õ type -examination
certificate.

3.2.        Under Tthe quality system, each explosive is examined and appropriate
tests as defined in the relevant standard(s) referred to in Article 4 or
equivalent tests are carried out in order to verify its conformity
ð shall ensure compliance of the
explosives with the type described in the EU type examination certificate
and ï with the Ö applicable Õ relevant
requirements of the
Ö this Õ Directive.

All the elements, requirements and provisions
adopted by the manufacturer must Ö shall Õ be documented
in a systematic and orderly manner in the form of written policies, procedures
and instructions. This quality system documentation must Ö shall
permit Õ enable Ö a
consistent interpretation of Õ the quality
programmes, plans, manuals and records to be interpreted in a uniform manner.

It must Ö shall, Õ in particular, contain an adequate description of:

ê 93/15/EEC

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

(a)     the quality objectives and the organiszational
structure, è1 responsibilities ç and powers of
the management with regard to product quality;,

(b)     the examinations
and tests that will be carried out after manufacture;,

ê 93/15/EEC
(adapted)

(c)     quality records, such as inspection reports and test data,
calibration data, qualification reports of the personnel concerned,; etc.

ê 93/15/EEC

(d)     the means of monitoring the effective operation of the quality
system.,

ê 93/15/EEC
(adapted)

ð new

3.3.        The notified body must Ö shall Õ assess the
quality system to determine whether it satisfies the requirements referred to
in 3.2.

It must Ö shall Õ presume
conformity with these Ö those Õ requirements
in respect of Ö the
elements of the Õ quality systems that ð comply with the corresponding
specifications of the national standard that ï implement
Ö implements Õ the relevant
harmoniszed
standard Ö and/or
technical specification Õ.

ð In addition to experience in quality
management systems, ï tThe
auditing team must
Ö shall Õ have at least
one member with experience of Ö evaluation Õ assessing
Ö in Õ the relevant
product Ö field and
product Õ technology Ö concerned Õ, ð and knowledge of the applicable
requirements of this Directive ï. The Ö audit Õ assessment procedure must
Ö shall Õ include an Ö assessment Õ inspection
visit to the manufacturer's premises. ð The auditing team shall review the
technical documentation referred to in point (e) of point 3.1, in order to
verify the manufacturer's ability to identify the relevant requirements of this
Directive and to carry out the necessary examinations with a view to ensuring
compliance of the explosive with those requirements. ï

Ö The
decision shall Õ The manufacturer must
be notified Ö to the
manufacturer Õ of the decision.
The notification must
Ö shall Õ contain the
conclusions of the Ö audit Õ examination
and the Ö reasoned Õ substantiated
assessment decision.

3.4.        The manufacturer must Ö shall Õ undertake to
fulfil the obligations arising out of the quality system as approved and Ö to Õ maintain it Ö so that
it remains Õ at an
adequate and efficient level.

3.5.        The manufacturer or his authorized representative must
Ö shall Õ keep the
notified body Ö that Õ which
has approved the quality system informed of any Ö intended Õ proposed
change Ö to Õ in the
quality system.

The notified body must Ö shall evaluate Õ assess Ö any
proposed Õ the
changes proposed
and decide whether the Ö modified Õ altered
quality system will Ö continue
to Õ still
satisfy the requirements referred to in point
3.2 or whether a reassessment is Ö necessary Õ required.

It must Ö shall Õ notify the
manufacturer of its decision. The notification Ö shall Õ must
contain the conclusions of the examination and the Ö reasoned Õ substantiated
assessment decision.

4.           Ö Surveillance
under the responsibility of the notified body Õ

4.1.        The purpose of Ö surveillance Õ monitoring
is to make sure that the manufacturer duly fulfils the obligations arising out
of the approved quality system.

4.2.        The manufacturer must Ö shall, for
assessment purposes, Õ allow the
notified body access for inspection purposes to the ð manufacture, ï inspection, testing and storage Ö sites Õ premises
and Ö shall Õ provide it
with all necessary information, in particular:

ê 93/15/EEC

(a)     the quality system documentation;,

–
the technical
documents,

ê 93/15/EEC
(adapted)

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

(b)     the quality records, such as inspection reports and test data,
calibration data, qualification reports Ö on Õ of the personnel concerned,
etc.

4.3.        The notified body must Ö shall Õ periodically
carry out Ö periodic Õ audits to Ö make
sure Õ ensure
that the manufacturer maintains and applies the quality system and must Ö shall Õ provide Ö the
manufacturer with Õ an audit
report to the
manufacturer.

4.4.        Ö In
addition Õ Additionally,
the notified body may pay Ö unexpected Õ unannounced
visits to the manufacturer. During such visits the notified body may Ö , if
necessary, Õ carry out Ö product Õ tests, or have them carried out, Ö in
order Õ to verify that
the quality system is functioning correctly.;
if necessary,
Tthe notified body must Ö shall Õ provide the
manufacturer with a visit report and, if a test has Ö tests
have Õ been carried
out, è1 with a test report. ç.

ò new

5.           Conformity
marking and declaration of conformity

5.1.        The
manufacturer shall affix the required conformity marking set out in this
Directive, and, under the responsibility of the notified body referred to in
point 3.1, the latter's identification number to each individual product that
is in conformity with the type described in the EU type examination certificate
and satisfies the applicable requirements of this Directive.

5.2.        The
manufacturer shall draw up a written declaration of conformity for each product
model and keep it at the disposal of the national authorities for 10 years
after the explosive has been placed on the market. The declaration of
conformity shall identify the explosive for which it has been drawn up.

A copy of the
declaration of conformity shall be made available to the relevant authorities
upon request.

ê 93/15/EEC
(adapted)

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

ð new

65.         The
manufacturer must
Ö shall, Õ for a period of ð ending ï at least 10 years after the ð the explosive has been placed on the
market, ï last date of manufacture of the product
keep at the disposal of the national authorities:

(a)     the documents
Ö documentation Õ referred to in
the
second indent of point
3.1;,

(b)     the changes referred to in the
second paragraph of point
3.53.4,
Ö as
approved; Õ

(c)     the decisions and reports Ö of Õ è1 from ç the notified
body which are
referred to in the final paragraph of points 3.53.4,
and in
4.3 and 4.4.

ò new

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.

ê 93/15/EEC
(adapted)

ð new

6. Each notified body must Ö shall
inform Õ forward to
the other notified bodies Ö of Õ the relevant information
concerning the quality system approvals Ö which it
has Õ issued and
ð refused, suspended or ï withdrawn ð , and, upon request, of quality
system approvals which it has issued ï.

ò new

8.           Authorised
representative

The manufacturer's
obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his
authorised representative, on his behalf and under his responsibility, provided
that they are specified in the mandate.

ê 93/15/EEC
(adapted)

ð new

5.
MODULE F:

Ö Conformity
to type based on Õ pProduct
verification

1.
This module describes the ð Conformity to type based on product
verification is the part of a conformity assessment ï procedure whereby Ö the Õ a manufacturer or his authorized
representative established within the Community checks and attests
ð fulfils the obligations laid down in
points 2, 5.1 and 6, and ensures and declares on his sole responsibility ï that the explosives Ö concerned,
which have been Õ subject to the
provisions of point 3, are in conformity with the type as
described in the EC
Ö EU Õ type -examination
certificate and satisfy the relevant requirements of the Ö this Õ Directive Ö that
apply to them Õ.

2.
Ö Manufacturing Õ

The manufacturer shall take all measures
necessary Ö so Õ in order
that the manufacturing process Ö and its
monitoring Õ ensures
conformity of the Ö manufactured
products Õ explosives
with the Ö approved Õ type as
described in the EC
Ö EU Õ type -examination
certificate and with the requirements of the Ö this Õ Directive that
apply to them. He shall affix the CE mark to each explosive
and shall draw up a declaration of conformity.

3.
Ö A Õ The
notified body Ö chosen by
the manufacturer Õ shall carry
out the
appropriate examinations and tests in order to check the conformity of the explosive
Ö explosives Õ with the ð approved type described in the EU
type examination certificate and with the appropriate requirements of this
Directive ï.

ð The examinations and tests to check
the conformity of the explosives with the appropriate ï relevant
requirements ð shall be carried out, at the choice
of the manufacturer either ï of the
Directive by examination and testing of every Ö product Õ explosive
as specified in Ö point Õ 4 ð or by examination and testing of the
explosives on a statistical basis as specified in point 5 ï.

ê 93/15/EEC

The manufacturer
or his authorized representative shall keep a copy of the declaration of
conformity for a period ending at least 10 years after the last explosive has
been manufactured.

ê 93/15/EEC
(adapted)

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

ð new

4.
Verification Ö of
conformity Õ by examination
and testing of every Ö product Õ explosive

4.1.
All Ö products Õ explosives
shall be individually examined and appropriate tests as set out in the relevant Ö harmonised Õ standard(s) Ö and/or
technical specifications, Õ referred to in Article 4
or equivalent tests, shall be
carried out in order to verify their conformity with the relevant Ö approved Õ type Ö described
in the EU type examination certificate Õ and Ö with the
appropriate Õ requirements
of the
Ö this Õ Directive. ð In the absence of such a harmonised
standard, the notified body concerned shall decide on the appropriate tests to
be carried out. ï

4.2.
The notified body Ö shall issue
a certificate of conformity in respect of the examinations and tests carried
out, and Õ è1 shall affix, ç or cause to be affixed,
its identification symbol
Ö number Õ to each
approved Ö product Õ explosive
Ö or have
it affixed under its responsibility Õ and draw up a written
certificate of conformity relating to the tests carried out.

ò new

The manufacturer
shall keep the certificates of conformity available for inspection by the
national authorities for 10 years after the explosive has been placed on the
market.

ê 93/15/EEC

4.3. The
manufacturer or his authorized representative shall ensure that he is able
to supply the notified body's certificates of conformity on request.

ò new

5.
Statistical
verification of conformity

5.1.
The manufacturer shall
take all measures necessary so that the manufacturing process and its
monitoring ensure the homogeneity of each lot produced, and shall present his
products for verification in the form of homogeneous lots.

5.2.
A random sample shall
be taken from each lot according to the requirements of this Directive. All
products in a sample shall be individually examined and appropriate tests set
out in the relevant harmonised standard(s) and/or technical specifications, or
equivalent tests, shall be carried out in order to verify conformity with the
approved type described in the EU type examination certificate and to ensure
their conformity with the applicable requirements of this Directive and to
determine whether the lot is accepted or rejected. In the absence of such a
harmonised standard, the notified body concerned shall decide on the
appropriate tests to be carried out.

5.3.
If a lot is accepted,
all products of the lot shall be considered approved, except for those products
from the sample that have been found not to satisfy the tests.

The notified body
shall issue a certificate of conformity in respect to the examinations and
tests carried out, and shall affix its identification number to each approved
product or have it affixed under its responsibility.

The manufacturer
shall keep the certificates of conformity at the disposal of the national
authorities for 10 years after the explosive has been placed on the market.

5.4.
If a lot is rejected,
the notified body or the competent authority shall take appropriate measures to
prevent that lot is being placed on the market. In the event of the frequent
rejection of lots the notified body may suspend the statistical verification
and take appropriate measures.

6.
Conformity marking and
declaration of conformity

6.1.
The manufacturer shall
affix the required conformity marking set out in this Directive, and, under the
responsibility of the notified body referred to in point 3, the latter's
identification number to each individual product that is in conformity with the
approved type described in the EU type examination certificate and satisfies
the applicable requirements of this Directive.

6.2.
The manufacturer shall
draw up a written declaration of conformity for each product model and keep it
at the disposal of the national authorities, for 10 years after the explosive
has been placed on the market. The declaration of conformity shall identify the
explosive for which it has been drawn up.

A copy of the
declaration of conformity shall be made available to the relevant authorities
upon request.

If the notified body
referred to in point 3 agrees and under its responsibility, the manufacturer
may also affix the notified body's identification number to the explosives.

7.
If the notified body
agrees and under its responsibility, the manufacturer may affix the notified
body's identification number to the explosives during the manufacturing
process.

8.
Authorised
representative

The manufacturer's
obligations may be fulfilled by his authorised representative, on his behalf
and under his responsibility, provided that they are specified in the mandate.
An authorised representative may not fulfil the manufacturer's obligations set
out in points 2 and 5.1.

ê 93/15/EEC
(adapted)

ð new

6.
MODULE G:

Ö Conformity
based on Õ uUnit verification

1.           This module describes the ð Conformity based on unit verification
is the conformity assessment ï procedure whereby the manufacturer ð fulfils the obligations laid down in
points 2, 3 and 5, and ï ensures and declares Ö on his
sole responsibility Õ that the
explosive Ö concerned, Õ which has been
Ö subject
to the provisions of point 4, is in conformity with the Õ issued with the
certificate referred to in Section 2 conforms to the relevant
requirements of the
Ö this Õ Directive Ö that
apply to it Õ. The manufacturer must affix the CE mark to the
explosive and draw up a declaration of conformity.

ê 93/15/EEC (new)

è1 Corrigendum,
OJ L 79, 7.4.1995, p. 34

2. The notified
body must examine the explosive and carry out the appropriate tests as set out
in the relevant standard(s) referred to in Article 4, or equivalent tests, to
ensure its conformity with the relevant requirements of the Directive.

The notified body
must affix, è1 or cause ç to be affixed, its identification symbol on
the approved explosive and draw up a certificate of conformity concerning the
tests carried out.

ê 93/15/EEC
(adapted)

ð new

2.           Ö Technical
documentation Õ

3. The aim
of ð The manufacturer shall
establish ï the technical documents Ö documentation Õ ð and make it available to the
notified body referred to in point 4. The documentation shall make it possible
to assess the explosive's ï is to
enable conformity with the Ö relevant Õ requirements ð , 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, ï of the
Directive to be assessed and the design, manufacture
and operation of the explosive to be understood.
The Ö technical Õ documents
Ö documentation Õ must Ö shall,
wherever applicable, Õ contain Ö at least
the following elements Õ, in so far as is
necessary for the assessment:

(a)     a general description of the Ö explosives Õ type;,

ê 93/15/EEC

(b)     conceptual design and manufacturing drawings and schemes of
components, sub-assemblies, circuits, etc.;,

ê 93/15/EEC
(adapted)

ð new

(c)     descriptions and explanations necessary for the understanding
of Ö those Õ the said
drawings and schemes and the operation of the explosive or protection system;,

(d)     a list of the Ö harmonised Õ standards ð and/or other relevant technical
specifications the references of which have been published in the Official
Journal of the European Union, ï referred
to in Article 4, applied in full or in part, and descriptions
of the solutions adopted to meet the essential requirements of the Ö this Õ Directive where
the
Ö those
harmonised Õ standards referred to in Article 4
have not been applied.,
ð In the case of partly applied
harmonised standards, the technical documentation shall specify the parts which
have been applied; ï

(e)     results of design calculations made, examinations carried out,
etc., Ö and Õ

(f)      test reports.

ò new

The manufacturer
shall keep the technical documentation at the disposal of the relevant national
authorities for 10 years after the explosive has been placed on the market.

3.           Manufacturing

The manufacturer
shall take all measures necessary so that the manufacturing process and its
monitoring ensure conformity of the manufactured product with the applicable requirements
of this Directive.

4.           Verification

A notified body
chosen by the manufacturer shall carry out appropriate examinations and tests,
set out in the relevant harmonised standards and/or technical specifications,
or equivalent tests, to check the conformity of the explosive with the
applicable requirements of this Directive, or have them carried out. In the
absence of such a harmonised standard and/or technical specification 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
product, or have it affixed under its responsibility.

The manufacturer
shall keep the certificates of conformity at the disposal of the national
authorities for 10 years after the explosive has been placed on the market.

5.           Conformity
marking and declaration of conformity

5.1.        The
manufacturer shall affix the required conformity marking set out in this
Directive and, under the responsibility of the notified body referred to in
point 4, the latter's identification number to each product that satisfies the
applicable requirements of this Directive.

5.2.        The
manufacturer shall draw up a written declaration of conformity and keep it at
the disposal of the national authorities for 10 years after the explosive has
been placed on the market. The declaration of conformity shall identify the
explosive for which it has been drawn up.

A copy of the
declaration of conformity shall be made available to the relevant authorities
upon request.

6.           Authorised
representative

The manufacturer's
obligations set out in points 2 and 5 may be fulfilled by his authorised
representative, on his behalf and under his responsibility, provided that they
are specified in the mandate.

é

ANNEX III

Repealed Directive with list of its
successive amendments
(referred to in Article 51)

Council Directive 93/15/EEC || (OJ L 121, 15.5.1993, p. 20)

Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1.) || Only point 13) of Annex II.

Regulation (EC) No 219/2009 (OJ L 87, 31.3.2009, p. 109.) || Only point 2.2 of the Annex.

ANNEX IV

Correlation table

Directive 93/15/EEC || This Directive

Article 1(1) || Article 1(1)

Article 1(2) || Article 2(1)

Article 1(3) || Article 1(2)

Article 1(4) || Article 2(2) – 2 (10)

Article 1(5) || Article 1(3)

Article 2(1) || Article 3

Article 2(2) || Article 4

- || Article 21

- || Article 21

Article 2(3) || Article 21

- || Article 21

Article 3 || Article 4, 6 (1)

- || Article 6 (2) – 6 (8)

- || Article 7

- || Article 8

- || Article 9

- || Article 10

Article 4(1) || Article 18

Article 4(2) || -

Article 5 || Article 19

Article 6(1) || Article 19

Article 6(2) || Articles 23 – 26

- || Article 28 – 39

Article 7(1) || Article 21 – 22

Article 7(2) || Article 21

Article 7(3) || Article 21

- || Article 40

Article 8(1) || Article 41, 43

Article 8(2) || Article 42

Article 8(3) || Article 44

Article 9(1) || Article 11(1)

Article 9(2) || -

Article 9(3) || Article 11(2)

Article 9(4) || Article 11(3)

Article 9(5) || Article 11(4)

Article 9(6) || Article 11(6)

Article 9(7) || Article 11(5)

Article 9(8) || Article 11(7)

Article 9(9) || Article 11(8)

Article 10(1) || Article 12(1)

Article 10(2) || Article 12(2)

Article 10(3) || Article 12(3)

Article 10(4) || Article 12(4)

Article 10(5) || Article 12(5)

Article 11 || Article 13

Article 12(1) || Article 14(1)

Article 12(2) || Article 14(2)

Article 13(1) || Article 47(1)

Article 13(2) || -

Article 13(3) || Article 45, 46

Article 13(4) || Article 47(2)

Article 13(5) || Article 45-46

Article 14, 1st subparagraph || Article 5

Article 14, 2nd subparagraph || Article 15, 1st subparagraph

Article 14, 3rd subparagraph || Article 15, 2nd subparagraph

Article 14, 4th subparagraph || Article 15, 3rd subparagraph

Article 15 || -

Article 16 || Article 16

Article 17 || Article 48

Article 18 || Article 17

Article 19 || Article 49-50

- || Article 51

- || Article 52

Article 20 || Article 53

Annex I || Annex I

Annex II || Annex II

Annex III || Article 27

Annex IV || Article 21

- || Annex III

- || Annex IV

[1]               Communication from the Commission to the European
Parliament, the Council, the Economic and Social Committee and the Committee of
the Regions, COM(2011) 206 final.

[2]               COM(2011) 315 final - Proposal for a Regulation of
the European Parliament and of the Council on European Standardisation and
amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC,
94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/105/EC and
2009/23/EC of the European Parliament and of the Council.

[3]               Regulation (EU) No 182/2011 of the European
Parliament and of the Council of 16 February 2011 laying down the rules and the
general principles concerning mechanisms for control by Member States of the
Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p.13).

[4]               OJ C 77, 28.3.2002, p.1.

[5]               OJ C [  ], [  ], p. [ ]

[6]               OJ L 121, 15.5.1993, p. 20.

[7]               OJ L 218, 13.8.2008, p. 30.

[8]               OJ L 218, 13.8.2008, p. 82.

[9]               OJ L 10, 14.1.1997, p. 13.

[10]             OJ L 256, 13.9.1991, p. 51.

[11]             OJ L 154, 14.6.2007, p. 1.

[12]             OJ No L 109, 26. 4. 1983, p. 8. Directive
as last amended by Commission Decision 90/230/EEC (OJ No L 128, 18. 5. 1990, p.
15).

[13]                    OJ C [  ], [  ], p. [ ]

[14]             OJ No L 380, 31. 12. 1990, p. 13.

[15]             OJ L 144, 2.6.1981, p. 1
82, 22.3.1997, p.1.

[16]                    OJ L 55, 28.2.2011, p.13.

[17]             OJ L 94, 5.4.2008, p. 8.