Parltrack

PURPOSE: to align Directive 2007/23/EC on the placing on the market of pyrotechnic articles 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 relating to the making available on the market of pyrotechnic articles 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 Directive 2007/23/EC. To ensure the readability of the amended text, the technique of recasting has been chosen on a more structured use of the recasting technique for legal acts. The proposal does not change the scope of the Directive and the essential safety requirements (apart from one point).

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 pyrotechnic 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 2007/23/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 2007/23/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 pyrotechnic 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.

OBJECTIF : alignement de la directive 2007/23/CE relative à la mise sur le marché d’articles pyrotechniques sur le nouveau cadre législatif, notamment la décision n° 768/2008/CE, qui a mis en place un cadre commun pour la commercialisation des produits.

ACTE PROPOSÉ : Directive du Parlement européen et du Conseil (paquet «Produits»).

CONTEXTE : au fil du temps, différentes lacunes et incohérences ont été constatées, tous secteurs confondus, dans la mise en œuvre et l’application effective de la législation d’harmonisation de l’Union, donnant lieu à:

• la présence de produits non conformes, voire dangereux, sur le marché et, par conséquent, une certaine perte de confiance dans le marquage CE,
• des désavantages concurrentiels pour les opérateurs économiques respectueux de la législation, par rapport à ceux qui contournent les règles en vigueur,
• des différences de traitement en ce qui concerne les produits non conformes et des distorsions de concurrence entre les opérateurs économiques en raison des pratiques différentes des autorités pour assurer le respect de la législation,
• des pratiques différentes appliquées par les autorités nationales pour la désignation des organismes d’évaluation de la conformité,
• des problèmes qualitatifs dans le cas de certains organismes notifiés.

Pour remédier aux lacunes générales de la législation d’harmonisation de l’Union, observées dans plusieurs secteurs d’activité industrielle, le nouveau cadre législatif, qui s’inscrit dans le paquet relatif aux produits, a été adopté en 2008. Il vise à renforcer et compléter les règles existantes ainsi qu’à améliorer des aspects pratiques de leur mise en œuvre et de leur application effective. Le nouveau cadre législatif est constitué de deux instruments complémentaires, à savoir le règlement (CE) n° 765/2008 relatif à l’accréditation et à la surveillance du marché et la décision n° 768/2008/CE relative à un cadre commun pour la commercialisation des produits.

La présente proposition relative à l’harmonisation des législations des États membres concernant la mise à disposition sur le marché d’articles pyrotechniques s’inscrit dans le cadre de la mise en œuvre du «paquet» législatif concernant les produits adopté en 2008; elle fait partie d’une série de propositions visant à aligner le texte de dix directives «produits» sur les dispositions de la décision n° 768/2008/CE, qui a mis en place un cadre commun pour la commercialisation des produits.

ANALYSE D’IMPACT : la Commission a procédé à une analyse d’impact, dans le cadre de laquelle les trois options suivantes ont été examinées et comparées.

• Option 1: aucune modification de la situation actuelle ;
• Option 2: alignement sur la décision du nouveau cadre législatif par des mesures non législatives;
• Option 3: alignement sur la décision du nouveau cadre législatif par des mesures législatives : les dispositions de la décision sont intégrées dans le dispositif des directives existantes.

L’option 3 a été jugée préférable pour les raisons suivantes: i) elle améliorera la compétitivité des entreprises et des organismes notifiés s’acquittant sérieusement de leurs obligations, par rapport à ceux qui contournent le système ; ii) elle améliorera le fonctionnement du marché intérieur en garantissant l’égalité de traitement pour tous les opérateurs économiques, notamment les importateurs et les distributeurs, ainsi que les organismes notifiés ; iii) elle ne représente pas de coûts importants pour les opérateurs économiques et les organismes notifiés ; iv) elle est jugée plus efficace que la deuxième option dans la mesure où cette dernière prévoit des mesures ayant force de loi.

BASE JURIDIQUE : article 114 du traité sur le fonctionnement de l’Union européenne.

CONTENU : l’alignement sur la décision du nouveau cadre législatif impose un certain nombre de modifications de fond des dispositions de la directive 2007/23/CE. Pour assurer la lisibilité du texte modifié, il a été décidé d’appliquer la technique de la refonte. La proposition ne modifie en rien (hormis sur un point) le champ d’application de la directive ni la teneur des exigences essentielles de sécurité.

Les principaux éléments de la proposition sont les suivants :

• Définitions universelles : la proposition prévoit des définitions uniformisées de termes qui sont communément employés dans la législation d’harmonisation de l’Union et qui devraient dès lors être interprétés de manière cohérente dans toute cette législation.
• Obligations des opérateurs économiques et exigences en matière de traçabilité : la proposition clarifie les obligations incombant aux fabricants et spécifie de nouvelles obligations en ce qui concerne les importateurs et les distributeurs. Les importateurs doivent notamment vérifier que les fabricants ont bien appliqué la procédure d’évaluation de la conformité requise et qu’ils ont établi la documentation technique. Les distributeurs ont l’obligation de vérifier que les articles pyrotechniques portent le marquage CE, mentionnent le nom du fabricant et de l’importateur le cas échéant et sont accompagnés de la documentation et des instructions requises.
• Obligations accrues en matière de traçabilité pour tous les opérateurs économiques : les articles pyrotechniques doivent porter les nom et adresse du fabricant, ainsi qu’un numéro permettant de les identifier et de les rattacher à la documentation technique concernée ; s’il s’agit d’articles pyrotechniques importés, les nom et adresse de l’importateur doivent aussi figurer sur ceux-ci ;
• Normes harmonisées : le respect des normes harmonisées confère une présomption de conformité aux exigences essentielles. La Commission a adopté une proposition de règlement relatif à la normalisation européenne qui prévoit des dispositions sur les demandes de normalisation adressées par la Commission aux organismes européens de normalisation, sur la procédure d’objection à l’encontre de normes harmonisées et sur la participation des parties prenantes au processus de normalisation. Par conséquent, les dispositions de la directive 2007/23/CE qui portent sur ces mêmes questions ont été supprimées dans la présente proposition pour des raisons de sécurité juridique. La disposition conférant la présomption de conformité aux normes harmonisées a été modifiée afin de clarifier la portée de celle ci lorsque les normes ne couvrent que partiellement les exigences essentielles.
• Évaluation de la conformité et marquage CE : la directive 2007/23/CE a déterminé les procédures appropriées d’évaluation de la conformité que les fabricants doivent appliquer en vue de démontrer que leurs articles pyrotechniques satisfont aux exigences essentielles de sécurité. La proposition aligne ces procédures sur leurs versions actualisées définies dans la décision du nouveau cadre législatif.
• Organismes notifiés : la proposition renforce les critères de notification applicables aux organismes notifiés. Elle précise que les filiales ou les sous traitants doivent aussi satisfaire à ces exigences. Elle définit de nouvelles exigences spécifiques concernant les autorités notifiantes et prévoit une procédure révisée pour la notification des organismes notifiés. Le certificat d’accréditation atteste la compétence d’un organisme notifié.
• Surveillance du marché et procédure de la clause de sauvegarde : la proposition modifie la procédure actuelle de la clause de sauvegarde. Elle introduit une phase d’échange d’informations entre les États membres et précise les démarches à accomplir par les autorités concernées lorsqu’un article pyrotechnique non conforme est identifié.

INCIDENCE BUDGÉTAIRE : la proposition n’a pas d’incidence sur le budget de l’UE.

ACTES DÉLÉGUÉS : la proposition contient des dispositions habilitant la Commission à adopter des actes délégués conformément à l’article 290 du traité sur le fonctionnement de l’Union européenne. 

PURPOSE: to align Directive 2007/23/EC on the placing on the market of pyrotechnic articles 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 relating to the making available on the market of pyrotechnic articles 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 Directive 2007/23/EC. To ensure the readability of the amended text, the technique of recasting has been chosen on a more structured use of the recasting technique for legal acts. The proposal does not change the scope of the Directive and the essential safety requirements (apart from one point).

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 pyrotechnic 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 2007/23/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 2007/23/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 pyrotechnic 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.