SP(2014)446

PURPOSE: to align Directive 93/15/EEC 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 with the new legislative framework, in particular to Decision No 768/2008/EC establishing a common framework for the marketing of products (Goods Package).

LEGISLATIVE ACT: Directive 2014/28/EU 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 (recast).

CONTENT: the Directive is part of a package aiming to recast eight directives in order to adapt them to the EU's new legislative framework on sectoral product harmonisation.

The recast seeks to further harmonise and simplify national laws applicable to:

· explosives for civil uses

· simple pressure vessels

· electromagnetic compatibility

· non-automatic weighing instruments

· measuring instruments

· lifts and safety components for lifts

· equipment for use in potentially explosive atmospheres

· electrical equipment designed for use within certain voltage limits .

The EU's "new legislative framework", which was adopted in 2008, is a general measure of the internal market with the objective of strengthening the effectiveness of the Union’s legislation on product safety and its implementation mechanisms. It aims to strengthen the safety of products available on the market, and ensures a better functioning internal market for instance through equal treatment of economic operators on the market.

It is made up of two complementary texts : regulation 765/2008 outlining the requirements concerning accreditation and surveillance for the marketing of products, and decision 768/2008/EC relating to a common framework for the marketing of products.

The main elements of the new Directive are as follows:

Purpose and scope : the Directive shall apply to explosives for civil uses . It aims to ensure that explosives on the market fulfil the requirements providing for a high level of protection of health and safety and other public interests while guaranteeing the functioning of the internal market. It should apply to all forms of supply, including distance selling.

This Directive shall not apply to : (i) explosives, including ammunition, intended for use, in accordance with national law, by the armed forces or the police; (ii) pyrotechnic articles falling within the scope of Directive 2013/29/EU; (iii) ammunition, except in cases provided for in the Directive.

A new Annex I, introduced by the Parliament, contains a non-exhaustive list of pyrotechnic articles and ammunition respectively identified following the United Nations recommendations on the transport of dangerous goods.

Obligations of economic operators and increased traceability requirements : the Directive clarifies the obligations of manufacturers and introduces obligations for importers and distributors:

· When placing their explosives on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the essential safety requirements set out in Annex II. Manufacturers shall ensure that explosives which they have placed on the market bear a unique identification in accordance with the system for the identification and traceability of explosives.

· 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.

· 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.

· Importers shall indicate, on the explosive, their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the explosive.

· The contact details of the manufacturer and importer shall be in a language easily understood by end-users and market surveillance authorities. Such instructions and safety information , as well as any labelling, shall be clear, understandable and intelligible.

· Economic operators 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 corrective measures necessary to bring that explosive into conformity, to withdraw it or recall it, if appropriate.

Identification and traceability of explosives : economic operators should adhere to a uniform system for the unique identification and traceability of explosives. Such a system 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.

Identification of economic operators : for explosives not covered by the identification and traceability of explosives system, economic operators should, on request, identify the following to the market surveillance authorities: (a) any economic operator who has supplied them with an explosive; (b) any economic operator to whom they have supplied an explosive.

Economic operators shall be able to present this information for 10 years after they have been supplied with the explosive and for 10 years after they have supplied the explosive.

Licence or authorisation : 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.

EU declaration of conformity : the EU declaration of conformity shall have the model structure set out in Annex IV. In order to reduce the administrative burden on economic operators, that single EU declaration of conformity may be a dossier made up of relevant individual declarations of conformity.

CE marking : the Directive provides that the CE marking shall be affixed visibly, legibly and indelibly to the explosive before it is placed on the market. Where that is not possible or not warranted on account of the nature of the explosive, it shall be affixed to the packaging and to the accompanying documents. As requested by the Parliament, Member States should build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.

Notified bodies : the Directive 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. A conformity assessment body shall be a third-party body independent of the organisation or the explosive it assesses. The impartiality of the conformity assessment bodies, their top level management and of the personnel responsible for carrying out the conformity assessment tasks shall be guaranteed.

Market surveillance and the safeguard clause procedure : the Directive 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 article is found. Member States should take all appropriate measures to ensure that explosives may be placed on the market only if, when properly stored and used for their intended purpose, or under conditions of use which can be reasonably foreseen, they do not endanger the health and safety of persons.

Restrictive measures in case of non-compliance : appropriate restrictive measures, such as withdrawal of the explosive from the market should be taken in respect of the explosive concerned without delay.

Rules on penalties applicable to infringements by economic operators could include criminal penalties for serious infringements. The penalties provided for should be effective, proportionate and dissuasive.

Transitional measures : Member States shall not impede the making available on the market of explosives covered by Directive 93/15/EEC which are in conformity with that Directive and which were placed on the market before 20 April 2016.

ENTRY INTO FORCE: 18/04/2014.

TRANSPOSITION: 19/04/2016. Measures should apply from 20/04/2016.

DELEGATED ACTS: the Commission shall be empowered to adopt delegated acts in accordance with Article 47 updating Annex I in order to align it to the United Nations recommendations on the transport of dangerous goods. The power to adopt delegated acts shall be conferred on the Commission for five years (renewable) from 18 April 2014 . The delegated act shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act (this period may be extended by two months). If the European Parliament and the Council object, the delegated act shall not enter into force.

Directive 2014/28
OJ L 096 29.03.2014, p. 0001

00047/2013/LEX

Results of vote in Parliament

The European Parliament adopted by 615 votes to 15, with 7 abstentions, a legislative resolution on the 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 (recast).

Parliament adopted its position at first reading following the ordinary legislative procedure. The amendments adopted in plenary are the result of an agreement reached between the European Parliament and the Council. They amended the proposal as follows:

Further align the Directive to the “new legislative framework” and ensure legal certainty : the amendments made by the Parliament seek to ensure that the proposed Directive is more consistent with the terms used by Decision No 768/2008/EC and to eliminate any inconsistencies in the text which could otherwise create legal uncertainty.

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.

Scope : this Directive shall apply to explosives for civil uses. The Directive shall not apply to: (a) explosives, including ammunition, intended for use, in accordance with national law, by the armed forces or the police; (b) pyrotechnic articles falling within the scope of Directive 2013/29/EU; (c) ammunition, except in cases provided for in the Directive.

The definition of ’ammunition’ has been introduced to mean projectiles with or without propelling charges and blank ammunition used in portable firearms, other guns and artillery.

This Directive should apply to all forms of supply, including distance selling .

Parliament introduced an Annex I containing a non-exhaustive list of pyrotechnic articles and ammunition respectively identified following the United Nations recommendations on the transport of dangerous goods.

Identification and traceability of explosives : economic operators should adhere to a uniform system for the unique identification and traceability of explosives, that takes into account their size, shape or design, except where it is not necessary to place a unique identification on the explosive due to its low level of hazard.

The system should provide for the collection and storage of data, including where appropriate by electronic means, enabling the unique identification and traceability of the explosive as well as for the placement of a unique identification on the explosive and/or its packaging enabling access to that data.

The data should be tested at regular intervals and protected against accidental or malicious damage or destruction and should be stored for 10 years after the transaction took place or, where the explosives have been used or disposed of, 10 years after their use or disposal, even if the economic operator has ceased trading.

Obligations of importers : manufacturers should ensure that explosives which they have placed on the market bear a unique identification in accordance with the system for the identification and traceability of explosives.

For explosives excluded from that system, manufacturers should indicate on the explosive their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the explosive.

Manufacturers should ensure that explosives which they have placed on the market 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. Such instructions and safety information, as well as any labelling, should be clear, understandable and intelligible .

In order to facilitate communication between economic operators, market surveillance authorities and end-users, Member States should encourage economic operators to include a website address in addition to the postal address.

Identification of economic operators : for explosives not covered by the identification and traceability of explosives system, economic operators should, on request, identify the following to the market surveillance authorities: (a) any economic operator who has supplied them with an explosive; (b) any economic operator to whom they have supplied an explosive.

Economic operators shall be able to present this information for 10 years after they have been supplied with the explosive and for 10 years after they have supplied the explosive.

Licence or authorisation : 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.

EU declaration of conformity : in order to reduce the administrative burden on economic operators, that single EU declaration of conformity may be a dossier made up of relevant individual declarations of conformity.

CE marking : Parliament called on the Member States to build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.

Notified bodies : a conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities. The impartiality of the conformity assessment bodies, their top level management and of the personnel responsible for carrying out the conformity assessment tasks shall be guaranteed.

Market surveillance : Member States shall take all appropriate measures to ensure that explosives may be placed on the market only if, when properly stored and used for their intended purpose, they do not endanger the health or safety of persons.

Where the market surveillance authorities of one Member State have sufficient reason to believe that an explosive presents a risk to the health or safety of persons, or to property or the environment, they should carry out an evaluation in relation to the explosive concerned.

Restrictive measures in case of non-compliance : appropriate restrictive measures, such as withdrawal of the explosive from the market should be taken in respect of the explosive concerned without delay. Rules on penalties applicable to infringements by economic operators could include criminal penalties for serious infringements.

Implementing measures : in order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on the Commission. The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to compliant explosives which present a risk to the health or safety of persons, or to property or the environment, imperative grounds of urgency so require.

When matters relating to this Directive, other than its implementation or infringements, are being examined, i.e. in a Commission expert group, the European Parliament should receive full information and documentation and, where appropriate, an invitation to attend such meetings.

T7-0085/2014

Debate in Parliament

A7-0256/2012

A7-0256/2012

PE491.120

PE488.066

COM(2011)0771

COM(2011)0771

PURPOSE: to align Directive 93/15/EEC 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 with the new legislative framework, in particular to Decision No 768/2008/EC establishing a common framework for the marketing of products (Goods Package).

PROPOSED ACT: Directive of the European Parliament and of the Council.

BACKGROUND: 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.

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/EC establishing a common framework for the marketing of products .

This proposal 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 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.

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; Option 2 – Alignment to the NLF Decision by non-legislative measures; 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 for the following reasons: (i) it will improve the competitiveness of companies and notified bodies taking their obligations seriously, as opposed to those cheating on the system; (ii) 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; (iii) it does not entail significant costs for economic operators and notified bodies; (iv) 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.

LEGAL BASIS: Article 114 of the Treaty on the Functioning of the European Union (TFEU).

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

The main elements of the proposal are as follows:

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. Obligations of economic operators and traceability requirements : the proposal clarifies the obligations of manufacturers 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 pyrotechnic articles are correctly marked and accompanied by instructions and safety information. They must keep a copy of the Declaration of conformity and indicate their name and address on the product, or where this is not possible on the packaging or the accompanying documentation. Distributors must verify that the article bears the CE marking, the name of the manufacturer and of the importer, if relevant, and that it is accompanied by the required documentation and instructions. 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 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/EC 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. Conformity assessment and CE marking : Directive 93/15/EC on the placing on the market of pyrotechnic articles has selected the appropriate conformity assessment procedures which manufacturers have to apply in order to demonstrate that their pyrotechnic articles comply with the essential safety requirements. The proposal aligns these procedures to their updated versions set out in the NLF Decision. 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. 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 article is found.

BUDGETARY IMPLICATIONS: this proposal does not have any implications for the EU budget.

DELEGATED ACTS: the proposal contains provisions empowering the Commission to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union.

COM(2011)0771
EUR-Lex

PURPOSE: to align Directive 93/15/EEC 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 with the new legislative framework, in particular to Decision No 768/2008/EC establishing a common framework for the marketing of products (Goods Package).

PROPOSED ACT: Directive of the European Parliament and of the Council.

BACKGROUND: 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.

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/EC establishing a common framework for the marketing of products .

This proposal 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 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.

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; Option 2 – Alignment to the NLF Decision by non-legislative measures; 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 for the following reasons: (i) it will improve the competitiveness of companies and notified bodies taking their obligations seriously, as opposed to those cheating on the system; (ii) 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; (iii) it does not entail significant costs for economic operators and notified bodies; (iv) 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.

LEGAL BASIS: Article 114 of the Treaty on the Functioning of the European Union (TFEU).

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

The main elements of the proposal are as follows:

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. Obligations of economic operators and traceability requirements : the proposal clarifies the obligations of manufacturers 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 pyrotechnic articles are correctly marked and accompanied by instructions and safety information. They must keep a copy of the Declaration of conformity and indicate their name and address on the product, or where this is not possible on the packaging or the accompanying documentation. Distributors must verify that the article bears the CE marking, the name of the manufacturer and of the importer, if relevant, and that it is accompanied by the required documentation and instructions. 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 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/EC 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. Conformity assessment and CE marking : Directive 93/15/EC on the placing on the market of pyrotechnic articles has selected the appropriate conformity assessment procedures which manufacturers have to apply in order to demonstrate that their pyrotechnic articles comply with the essential safety requirements. The proposal aligns these procedures to their updated versions set out in the NLF Decision. 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. 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 article is found.

BUDGETARY IMPLICATIONS: this proposal does not have any implications for the EU budget.

DELEGATED ACTS: the proposal contains provisions empowering the Commission to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union.

COM(2011)0771
EUR-Lex