COMMUNICATION DE LA COMMISSION AU PARLEMENT EUROPÉEN ET AU CONSEIL sur le rôle de la normalisation européenne dans le cadre des politiques et de la législation européennes {SEC (2004) 1251}(Texte présentant de l'intérêt pour l'EEE)

1. Résumé

La normalisation fait partie intégrante des politiques du Conseil et de la Commission visant à «mieux légiférer», à renforcer la compétitivité des entreprises et à éliminer les barrières au commerce au niveau international. Cela a été confirmé par le Parlement européen en 1999 [1] ainsi que par le Conseil dans sa résolution du 28 octobre 1999 [2] et dans ses conclusions du 1er mars 2002 [3] sur le rôle de la normalisation en Europe. Dans le même temps, le Conseil a invité la Commission à réexaminer les objectifs, le champ d'application et les besoins de la politique européenne en matière de normalisation. La Commission a accepté cette invitation, analysé la situation actuelle et identifié les principaux domaines dans lesquels le système européen de normalisation et les instruments disponibles pour la politique européenne de normalisation peuvent et devraient être encore améliorés. Les résultats de cette analyse font l'objet de deux documents. Le premier est la présente communication, qui souligne l'importance accrue de la normalisation pour soutenir les politiques de l'UE. Le deuxième est un document de travail de la Commission traitant des «défis pour la normalisation européenne», qui est axé sur l'analyse des défis auxquels la normalisation européenne est confrontée dans une économie en perpétuel changement et vise à fournir des recommandations sur la meilleure manière de relever ces défis.

[1] Résolution sur le rapport de la Commission au Conseil et au Parlement européen «Efficacité et légitimité en matière de normalisation européenne dans le cadre de la nouvelle approche», JO C 150 du 28.5.1999

[2] Résolution du Conseil du 28 octobre 1999 sur «le rôle de la normalisation en Europe» (JO C141 du 2000 05-19)

[3] Conclusion du Conseil sur la normalisation du 1er mars 2002, (JO C66 du 2002-03-15)

L'analyse a montré que le système actuel de normalisation en Europe, qui est essentiellement défini par la directive 98/34 [4], a produit ce qu'il était censé produire. La normalisation européenne s'est avérée un outil efficace dans l'achèvement du Marché unique pour les marchandises.

[4] Directive 98/34 du Parlement européen et du Conseil prévoyant une procédure d'information dans le domaine des normes et réglementations techniques, JO L 204 du 21.7.1998, modifiée par la directive 98/48 du Parlement européen et du Conseil, JO L 217 du 5.8.1998.

Il subsiste néanmoins des possibilités d'améliorations qui affectent toutes les parties prenantes à la normalisation européenne, en commençant par la Commission européenne elle-même, les organismes européens de normalisation (OEN), les organismes nationaux de normalisation, les autorités nationales, les entreprises et jusqu'aux organisations non gouvernementales qui s'intéressent à la normalisation.

- La normalisation européenne a apporté une contribution importante au fonctionnement de la législation du Marché unique. Depuis 1998, environ 20 nouveaux actes et projets législatifs dans lesquels les normes jouent un rôle de soutien ont été élaborés et mis en oeuvre. Ceux-ci traitent, en particulier, des TIC, de l'environnement et de la protection des consommateurs. On peut en conclure qu'au moyen de la nouvelle Approche ou au-delà de celle-ci, l'utilisation des normes pour soutenir la législation pourrait être étendue à de nouveaux domaines de la législation européenne. La Commission continuera à promouvoir, conformément à son engagement à mieux légiférer, l'utilisation plus large des normes pour soutenir la législation. La normalisation européenne peut jouer un rôle important pour accroître la compétitivité des entreprises européennes. Pour cela, il faut que le système de normalisation européenne volontaire développe des activités dans tous les domaines qui sont importants pour le bon fonctionnement du Marché intérieur, au-delà du Marché unique pour les marchandises, par exemple, dans les services, les TIC, la protection des consommateurs et de l'environnement.

- Dans ce contexte, cependant, la normalisation européenne doit répondre correctement aux besoins du marché, en particulier à ceux de l'industrie. La Commission est au courant des critiques formulées quant à l'efficacité et à la rapidité du processus d'élaboration des normes, en particulier dans le domaine des nouvelles technologies telles que les TIC, dans lequel un développement rapide de la normalisation est nécessaire pour répondre aux exigences d'un marché en rapide évolution. Les spécifications élaborées par les forums et les consortiums industriels jouent un rôle de plus en plus important, en particulier au niveau international. La Commission considère qu'il existe un énorme potentiel d'amélioration de l'efficacité et de l'efficience du système de normalisation européen et de ses mécanismes pour répondre aux besoins du marché et des entreprises dans des conditions en perpétuel changement. Sachant que la normalisation européenne est indépendante et axée sur les entreprises, les organismes européens de normalisation sont invités, ainsi que les parties prenantes, à vérifier si leurs méthodes de travail, leurs procédures et leurs politiques reflètent suffisamment les besoins des parties prenantes en ce qui concerne l'offre d'une meilleure réponse aux exigences actuelles du marché.

- En tant que contribution de la part de l'UE pour conférer une valeur ajoutée à la normalisation dans le contexte des politiques de l'UE, le cadre institutionnel doit être révisé afin d'assurer que la normalisation puisse effectivement jouer son rôle. Cela implique la création d'une base juridique pour le financement de la normalisation européenne et une révision de la partie consacrée aux normes de la directive 98/34 prévoyant une procédure d'information dans le domaine des normes et réglementations techniques.

- La Commission, en coopération avec les organismes européens de normalisation, continuera d'encourager le développement de normes internationales par les organes de normalisation internationaux appropriés et de promouvoir leur utilisation. Lorsque des normes internationales existent, elles seront, chaque fois que possible, transposées de façon uniforme par les organismes européens de normalisation et utilisées comme base pour la législation communautaire.

- La Commission estime que le système européen de normalisation et ses réalisations pourraient être rendus encore plus visibles à l'extérieur de l'UE afin de présenter les avantages du modèle d'harmonisation européen, en particulier aux nouveaux «voisins» de l'UE après l'élargissement. Dans sa récente communication sur la «Politique européenne de voisinage» [5], la Commission a explicitement souligné l'importance de l'évaluation de la conformité et de la normalisation dans ce contexte. En outre, davantage de synergies devraient être créées par une coopération accrue entre les organismes européens de normalisation, leurs membres nationaux, la Commission et les États membres afin de rendre la normalisation européenne plus visible à l'extérieur de l'Europe [6].

[5] COM (2004) 373 final

[6] voir document de travail de la Commission «the challenges for European standardisation» http://europa.eu.int/comm/enterprise/standards_policy/index.htm (à paraître)

2. domaines politiques réceptifs aux nouvelles normes

2.1 Nouvelle législation et nouvelles initiatives législatives

La normalisation européenne, en tant que soutien de la législation «Nouvelle Approche» s'est avérée un outil efficace et essentiel dans l'achèvement du Marché unique pour les marchandises. Dans ses conclusions du 1er mars 2002 sur la normalisation européenne, le Conseil a confirmé ce succès. Il a demandé à la Commission d'examiner si le soutien apporté par les normes européennes à la législation européenne pourrait être étendu à de nouveaux domaines politiques, même au-delà de la législation du Marché unique.

Dans ce contexte, il convient de souligner que la «Nouvelle Approche» s'est avérée un modèle de législation spécifique par lequel l'intérêt public (c'est-à-dire la protection de la santé publique et la sécurité, la protection des consommateurs et de l'environnement) et l'intérêt des entreprises privées à produire des normes correspondant à l'«état de l'art» pertinent, pouvaient être fusionnés d'une manière adéquate. Elle permet des formes plus souples et moins contraignantes de législation dans des domaines où, sinon, chaque détail devrait être déterminé par l'acte législatif lui-même.

Déjà dans son «Rapport intermédiaire au Conseil et au Parlement européen sur les actions menées conformément aux résolutions sur la normalisation européenne adoptées par le Conseil et le Parlement européen en 1999», la Commission a rendu compte de ses initiatives visant à élargir l'utilisation faite des normes pour soutenir sa législation et ses politiques [7]. Depuis la nouvelle demande du Conseil de mars 2002 de maintenir cette approche et dans le contexte, d'une part, du besoin de simplifier la législation dans la perspective de l'élargissement de l'Union européenne et, d'autre part, des activités proposées pour actualiser et simplifier l'acquis [8], de nouveaux progrès ont été accomplis par un large éventail d'initiatives dans la législation et les politiques communautaires. Ces initiatives concernent en particulier la politique «Mieux légiférer» [9] de la Commission, les TIC, les services, les transports, la protection des consommateurs et la protection de l'environnement.

[7] pour plus de détails, voir COM (2001) 527 final, p. 9 et suivantes

[8] COM (2003) 71

[9] Rapport de la Commission sur la gouvernance européenne, décembre 2002, COM (2002) 705 final. Dans le cadre de sa politique visant à mieux légiférer, la Commission s'est engagée à réaliser plus systématiquement une évaluation d'impact pour les projets législatifs importants. Dans ce contexte, les alternatives et la solution la moins contraignante doivent être examinées. La référence à des normes volontaires est l'un des moyens.

Il est donc hautement souhaitable d'étendre l'utilisation faite des normes dans des domaines relevant de la législation communautaire au-delà du marché unique, en tenant compte des spécificités des domaines concernés, conformément aux propositions «Gouvernance» et «Mieux légiférer» de la Commission.

2.2 La normalisation à l'appui de la compétitivité de l'industrie

Les avantages de la normalisation européenne vont bien au-delà du simple soutien de la législation européenne. L'élaboration de normes volontaires par les parties prenantes peut apporter une valeur ajoutée supplémentaire et renforcer la compétitivité [10]. Les normes font depuis très longtemps partie intégrante du système de marché et ont joué un rôle clé dans l'enrichissement des nations. Les normes tendent à renforcer la concurrence et permettent d'abaisser les coûts de production et de vente, au bénéfice de l'ensemble des économies. Les normes opèrent en réduisant la variété, en assurant l'interopérabilité, en maintenant la qualité et en fournissant des informations. Une étude récente publiée par l'un des grands organismes nationaux de normalisation a estimé qu'en Europe, la normalisation ajoute approximativement 1% à la valeur du produit intérieur brut [11]. Il a également été souligné que la valeur ajoutée générée par la normalisation est au moins aussi importante que celle générée par les brevets. Cela confirme pourquoi la normalisation est si importante pour les politiques européennes. La Commission est bien consciente de ces faits et a, par conséquent, incorporé l'utilisation des normes dans différents documents relatifs à ses politiques.

[10] Ainsi, selon une étude publiée par l'organisme autrichien de normalisation ON («Der Nutzen der Normung für Unternehmen und Volkswirtschaft», p. 20), les bénéfices de la normalisation en Autriche se chiffrent à 1,74 milliard d'euros contre 43 millions d'euros pour les coûts. Les bénéfices sont donc 40 fois supérieurs aux coûts.

[11] «Economic benefits of standardisation», publié par DIN (Institut allemand de normalisation) 2000 ISBN 3-410- 1486- 4

2.2.1 Améliorer le Marché intérieur pour les biens et les services

Dans sa Stratégie pour le Marché intérieur 2003-2006 [12], la Commission a élaboré un plan en dix points pour améliorer le fonctionnement du Marché intérieur. Les priorités comprennent, en particulier, l'amélioration de la libre circulation des marchandises et la concrétisation de la libre circulation des services.

[12] Communication de la Commission: Stratégie pour le Marché intérieur - Priorités 2003 - 2006, COM (2003) 238 final

Les secteurs de services (par exemple, les services aux entreprises, les transports, les télécommunications, le tourisme et les loisirs) représentent un pourcentage considérable de l'emploi total (70% de l'emploi total dans les services marchands) [13] dans l'économie de marché de l'Union européenne Cependant, la disponibilité de normes volontaires dans le domaine des services présente un retard considérable par rapport à l'importance économique et au potentiel de ce domaine [14]. Les normes européennes sont reconnues comme l'une des mesures pouvant améliorer le commerce intra-UE dans les services et renforcer la compétitivité. En conséquence, la Commission a invité les organismes européens de normalisation à mettre sur pied un programme visant à identifier, en coopération avec les parties prenantes, les domaines prioritaires pour la normalisation européenne et à amorcer un processus dynamique de normalisation au niveau européen.

[13] Les services marchands comprennent tous les services sauf ceux assurés par les pouvoirs publics.

[14] voir dans ce contexte «Standards in the Service Sectors, Institut Fraunhofer sur les systèmes et l'innovation, avril 2003, p. 1, 2

En outre, la Commission déplore qu'en dépit de l'existence d'un remarquable ensemble de normes communes, les systèmes de certification et les labels de qualité nationaux restent dispersés. Les producteurs qui souhaitent mettre leurs produits sur le marché de l'UE se sentent donc souvent obligés de démontrer la conformité de leur produit et y apposant la marque de certification nationale pertinente. Ce serait en particulier un énorme progrès de pouvoir s'appuyer sur un système de labels européens communs pour attester, sur une base volontaire, la conformité à des normes volontaires. Les organismes européens de normalisation, leurs membres nationaux, les États membres et les parties prenantes sont invités à rechercher des solutions pour améliorer l'approche dans ce domaine.

2.2.2 Innovation

Les normes jouent également un rôle important pour l'innovation et influencent donc les décisions d'investissement des entreprises en matière de R&D. En tant que source des connaissances techniques les plus récentes, les normes élargissent la base de connaissances de l'économie et peuvent intégrer harmonieusement des nouvelles technologies et des résultats de la recherche dans la conception et le processus de développement de nouveaux produits et services. En tant qu'instrument de marché, les normes aident les entreprises à créer un langage d'échange commun. Un exemple frappant est le GSM («Global System for Mobile Communications»), qui a créé un marché international pour les communications mobiles et constitue la force motrice du développement de nombreuses applications mobiles. Par ailleurs, en ce qui concerne la nouvelle infrastructure de navigation par satellite «Galileo», les normes européennes et internationales apportent un appui similaire non seulement pour sa mise en oeuvre mais également pour son utilisation dans un large éventail d'applications. La facilité d'introduction de dispositifs et services Galileo sur le marché mondial dépend de l'acceptation à l'échelle la plus large des normes pertinentes. La recherche prénormative (recherche visant à fournir une base scientifique pour les normes) contribue à mettre en place un environnement économique propice à l'investissement dans la R&D et l'innovation. Il est donc important de renforcer le lien entre les activités de recherche et la normalisation en vue d'optimiser le bénéfice pour la normalisation.

2.2.3 Normalisation et TIC/TI

Les normes peuvent contribuer à créer et à assurer l'interopérabilité et donc à éviter la fragmentation des marchés. Cela est particulièrement important dans des marchés en rapide évolution avec des technologies en perpétuel changement, notamment dans le domaine des TIC. Ce marché a changé radicalement et continuellement au cours de la dernière décennie. Sa libéralisation a suscité une concurrence entre secteurs. Le monde monolithique du passé a été remplacé par un développement technologique hétérogène.

On assiste à une transition significative du matériel vers le logiciel. Elle implique une réorientation des formes traditionnelles de normalisation vers des cycles de développement et d'exploitation à court terme. Elle crée des voies parallèles menant aux normes afin d'atteindre l'objectif d'interopérabilité qui est une exigence essentielle pour éviter la fragmentation du marché et requiert d'accélérer l'obtention des normes et la promotion des nouveaux résultats obtenus. En outre, les télécommunications et les TI convergent et les marchés sont devenus mondiaux, ce qui a donné lieu à de nouvelles structures de marché et à un partenariat industriel mondial. De ce fait, les consortiums et les forums jouent un rôle de plus en plus important dans l'élaboration des normes, remettant en question le rôle et les structures des OEN ainsi que l'intervention des pouvoirs publics au niveau de l'UE. La normalisation à l'appui de la législation dans le secteur des TIC devrait être révisée.

La normalisation européenne ainsi que les organismes européens de normalisation doivent reconnaître ces faits et revoir leurs politiques, processus et structures organisationnelles, en collaboration étroite avec les parties prenantes et, en particulier, l'industrie afin d'offrir une meilleure réponse à des exigences différentes du marché.

2.3 La normalisation à l'appui des besoins sociétaux

2.3.1 Environnement

Dans sa communication sur une Politique intégrée des produits [15], la Commission a indiqué que les normes ont un potentiel considérable pour soutenir le développement durable, dans ses aspects économiques, sociaux et environnementaux. Elle considère également les normes comme l'un des outils dont l'amélioration pourrait contribuer à mettre en place le cadre pour l'amélioration environnementale continue des produits tout au long de leur cycle de vie. Les normalisateurs sont désormais encouragés à accorder une plus grande attention à l'environnement. Aussi, dans sa récente Communication sur l'intégration des aspects environnementaux dans la normalisation [16], la Commission a résolument encouragé toutes les parties prenantes à adopter des mesures durables visant à intégrer la protection de l'environnement dans la normalisation [17].

[15] COM (2003) 302

[16] COM (2004) 130 final du 25 février 2004

[17] Concrètement, la Commission a émis un mandat pour la programmation de travaux de normalisation dans le domaine de l'éco-conception des produits consommant de l'énergie; ce mandat a été accepté par les organismes européens de normalisation et les travaux devraient commencer bientôt.

2.3.2 Accessibilité pour tous

Les normes sont un important instrument pour intégrer davantage la société et l'économie. En Europe, la société vieillit. Il existe donc un marché en expansion pour les biens et services qui répondent aux besoins des personnes invalides et/ou âgées. La normalisation a la capacité de relever à ce défi et de paver la voie pour l'introduction de technologies de pointe innovantes qui assurent l'accessibilité pour tous. Cela exige cependant un engagement ferme de la part de toutes les parties prenantes impliquées dans ce processus.

2.3.3 Sécurité

La normalisation devrait également jouer un rôle important dans le contexte des politiques en matière de sécurité, de lutte contre le terrorisme et de prévention de la criminalité visant à protéger les citoyens, les infrastructures et les services qui sont des cibles potentielles.

3. La dimension mondiale de la normalisation

Les principaux engagements internationaux de l'Union européenne dans ce domaine sont exprimés par l'Accord de l'OMC sur les obstacles techniques au commerce. Entre autres, cet Accord requiert de ses signataires que les règlements techniques et les normes internationales soient élaborés et mis en oeuvre de façon non discriminatoire et sans créer d'obstacles superflus au commerce. Il recommande également le recours aux normes internationales, chaque fois que possible, lors de la rédaction de règlements techniques.

La Commission, en coopération avec les organismes européens de normalisation, prône l'utilisation des normes internationales. À cet égard, elle participe à des dialogues commerciaux tels que le TABD [18] et le MEBF [19], elle soutient les accords de coopération et de partenariat entre organismes européens et internationaux de normalisation, elle promeut des modèles réglementaires adossés aux normes à l'instar de la Commission économique des Nations unies pour l'Europe (CEE/NU) et assure une assistance technique. Ces initiatives visent à ouvrir les marchés à l'industrie européenne et à doper sa compétitivité.

[18] Trans Atlantic Business Dialogue

[19] Mercosur European Business Forum

Cependant, pour être en mesure d'accomplir cette tâche et pour démontrer l'efficacité du système européen, la Communauté a besoin d'un système de normalisation puissant comprenant une infrastructure suffisante au niveau européen, qui soit capable d'assurer que les normes internationales, élaborées et transposées dans les normes européennes pour soutenir les politiques communautaires soient cohérentes avec ces politiques. Un système diversifié basé sur de nombreux organismes nationaux de normalisation concurrents ne pourrait jamais jouer un tel rôle. Les États membres, leurs organismes nationaux de normalisation et les parties prenantes sont donc invités à continuer de soutenir un système de normes européennes fort et cohérent. Dans le même temps, il est nécessaire que l'industrie européenne et les parties prenantes soient pleinement engagées dans la normalisation européenne de telle sorte qu'elles puissent être une force motrice au niveau de la normalisation internationale.

4. Recommandations en vue d'autres initiatives

Les consultations menées avec les États membres et les parties prenantes dans la normalisation ont confirmé les vues de la Commission en ce qui concerne la politique de normalisation. Elles ont également confirmé qu'il était nécessaire d'apporter des améliorations requérant un ensemble complet d'activités de suivi, qui sont détaillées dans le document de travail de la Commission sur «les défis pour la normalisation européenne». La Commission mettra en oeuvre les recommandations d'actions décrites ci-dessous. En outre, elle invite les organismes européens de normalisation, les États membres et les parties prenantes à engager ces actions dans leurs propres domaines de compétence. La mise en oeuvre des recommandations pourrait conduire à de nouvelles initiatives, qui seront définies dans un plan d'action élaboré par la Commission en conjonction avec les États membres et les parties prenantes.

Ces recommandations d'actions sont les suivantes:

4.1. Continuer à faire un usage plus étendu de la normalisation européenne dans les politiques et la législation européennes.

- La Commission est convaincue que l'extension de l'utilisation faite des normes pour soutenir la législation et les politiques européennes dans des domaines qui vont au-delà du Marché unique pour les marchandises a été un succès. La Commission s'engage à maintenir cette approche et à soutenir une utilisation étendue des normes dans ses politiques.

- Dans ce contexte, il est important de mieux sensibiliser les décideurs des États membres aux avantages de la normalisation européenne pour soutenir la législation et les politiques communautaires.

4.2. Amélioration de l'efficacité, de la cohérence et de la visibilité de la normalisation européenne et de son cadre institutionnel

- Efficacité: il est essentiel que les normes européennes soient élaborées dans des délais raisonnables. À cette fin, les organismes européens de normalisation doivent continuer à améliorer substantiellement leur efficacité afin de répondre correctement aux besoins de l'industrie et des autorités de réglementation. Cela concerne également la disponibilité de procédures par lesquelles les besoins des consortiums pourraient être mieux pris en compte dans les OEN. Les OEN devraient exploiter pleinement les synergies possibles en améliorant leur coopération et renforcer leurs mécanismes de coordination pour les sujets d'intérêt commun.

- TIC: la Commission tentera d'amorcer une analyse stratégique, en concertation avec les États membres et les parties prenantes, visant à examiner comment l'ensemble des acteurs impliqués dans la normalisation pourraient mieux répondre aux défis de satisfaire les besoins de la société et du marché, en fournissant des spécifications élaborées efficacement dans le secteur des TI.

- La participation effective de toutes les parties intéressées concernées (ONG, environnement, consommateurs, PME, autorités, représentants d'entreprises conformément à l'esprit de l'Accord OTC) n'est pas encore suffisamment bien garantie, ni au niveau des OEN, ni dans tous les États membres. Des améliorations sont nécessaires. Nous devons également redoubler d'efforts afin que la normalisation européenne soit reconnue par les entrepreneurs comme un outil stratégique pour la compétitivité et pour l'application uniforme de la réglementation technique dans le marché intérieur. À cet égard, l'engagement de chacun doit être réactivé.

- Renforcement du cadre institutionnel: le cadre institutionnel doit être réformé afin d'assurer que la normalisation puisse effectivement jouer son rôle. Cela implique la création d'une base juridique pour le financement de la normalisation européenne et une révision de la partie consacrée aux normes de la directive 98/34 prévoyant une procédure d'information dans le domaine des normes et réglementations techniques.

- Viabilité financière de la normalisation européenne: le financement de la normalisation européenne doit s'appuyer essentiellement sur les contributions des parties concernées. Compte tenu du rôle joué par la normalisation européenne pour soutenir les politiques européennes, la Commission s'engage à cofinancer les activités de normalisation européennes et les infrastructures européennes. Les États membres assument une co-responsabilité en ce qui concerne la viabilité financière du système européen de normalisation. Le financement de l'infrastructure centrale du CEN/CENELEC, qui jusqu'à présent dépend exclusivement des contributions de l'UE et des contributions annuelles des organismes nationaux de normalisation, devrait être révisé en vue de l'asseoir sur une base plus large. Le maintien d'infrastructures centralisées fortes représentant l'intérêt européen est essentiel. La Commission soumettra une proposition législative donnant une base juridique au soutien financier de la normalisation européenne, avec référence à l'ensemble de ces activités et besoins, en tant qu'outil servant les politiques européennes.

4.3 La normalisation européenne et le défi de la mondialisation

- La Commission continuera de promouvoir les normes internationales établies par les organismes internationaux de normalisation (ISO, IEC, ITU) et de soutenir leur transposition dans l'UE.

- Lorsque des normes internationales sont élaborées et transposées en normes européennes pour soutenir les politiques européennes, les organismes européens de normalisation doivent veiller à ce que ces normes soient compatibles avec les objectifs des politiques de l'UE.

- Le rôle de la normalisation européenne dans le contexte international et la visibilité de ses réalisations pour améliorer l'accès au marché et la compétitivité doivent être renforcés. Il est important d'inviter l'industrie européenne et les parties concernées à réitérer leur engagement envers la normalisation européenne en tant que force motrice pour la normalisation internationale. Il convient également de vérifier l'engagement des États membres (dans la perspective de l'élargissement) envers la normalisation européenne. Les organismes européens de normalisation et les parties prenantes sont encouragés à entreprendre des actions concrètes pour améliorer la visibilité.

COMMISSION STAFF WORKING DOCUMENT

"The challenges for European standardisation"

{COM(2004)674 final}

COMMISSION STAFF WORKING DOCUMENT

"The challenges for European standardisation"

Introduction

This paper has been developed in support of a Commission Communication on the "Role of European Standardisation in the Framework of European Legislation and Policies". As a follow-up of the European Parliament's Resolution in 1999 [20] and of both the Council Resolution of 28 October 1999 [21] and the Council Conclusions of 1 March 2002 [22] on European standardisation, the Commission has analysed the areas in which standards play a role to support European legislation and policies beyond the legislation establishing the Single Market for goods and services (see annexes 1 and 2). At the same time, it has identified, in the light of the changing conditions under which European standardisation in the enlarged EU needs to operate and taking account of the challenges due to digitalisation and globalisation, the challenges the European standardisation system is currently faced with and the instruments available to European standardisation policy. The first conclusions were discussed with stakeholders in standardisation via public web consultations. This analysis will demonstrate that the actions proposed to meet needs in an ever-changing environment are not only addressed to the European Standards Organisations (ESOs), but related to all stakeholders in European standardisation, comprising the European Commission, national authorities, the European Standards Organisations, National Standards Bodies, industry and NGOs. The particular objective of the following Commission staff working document is to explain the specific challenges European standardisation is facing and to provide recommendations for further activities, aimed at all stakeholders in standardisation.

[20] Resolution on the report from the Commission to the Council and the European Parliament "Efficiency and Accountability in European standardisation under the New Approach", OJ C 150 of 28.5.1999

[21] Council Resolution of 28 October 1999 on "the Role of Standardisation in Europe" (OJ C141 of 2000 05-19)

[22] Council conclusions on standardisation of 2002-03-01, (OJ C66 of 2002-03-15)

1. Enlargement

European legislation and policies supported by standards can only work properly when they are complemented by a sound and well functioning European standards system including all of the Member States' National Standards Bodies .

The National Standards Bodies of the new Member States undertook enormous efforts to become full members in the European standards system by 1st January 2004. The Commission recognises these efforts. However, besides full membership of National Standards Bodies from the new Member States, there still remains the challenge of the full integration of these organisations into the "European standardisation culture". Therefore, the standards bodies of the new Member States should actively contribute to European standardisation. Where infrastructures in the new Member States are not yet fully operational, national governments, the relevant National Standards Bodies and stakeholders will need to make further efforts. National governments, the standards organisations and stakeholders from the new Member States are invited to contribute fully to the European system.

Due to the structure and size of enterprises in the new Member States, the involvement of Small and Medium-sized enterprises (SMEs) in standardisation work and the use of European standards present a particular problem in the sense that access to standards must be improved. The Commission notes that there is a particular need for actions to enhance the availability of standards in the languages of the new Member States and to improve involvement of SMEs in European standardisation.

2. The strategic importance of standardisation for enterprises and efficiency

For enterprises, the use of standards is a strategic tool to raise competitiveness. However, in many cases, high level management in industry is not aware of the strategic advantages the use of standards and their participation in standardisation work have for their enterprises. Moreover, standardisation is seen as a cost. Accordingly, there is a tendency, when needing to reduce costs, to save money by firstly reducing the participation of their employees in standardisation work. Such a decision will, in the medium-term, lead to strategic disadvantages for these enterprises and affect their position in the market. The awareness of senior managers of enterprises with respect to the advantages of standardisation must therefore be improved.

At the same time, efficiency in the standards development process must be improved. The speed of transposition of European standards into national standards must be increased. The latest Internal Market Scoreboard reports on the transposition deficit records of National Standards Bodies [23]. The reduction of delays in the development of standards is one of the main objectives in the European standardisation infrastructure. To some extent, however, a certain timeframe for the development of standards has to be accepted, since one of the indispensable core elements for the acceptance of voluntary standards is consensus. Consensus building needs, by its very nature, a certain time frame. A balance between efficiency and openness, in particular with respect to the enlarged ESOs (with up to 30 members), must be maintained.

[23] Internal Market Scoreboard n° 13 of July 2004, available at http://europa.eu.int/comm/internal_market/score/index_en.htm"

There are, of course, other factors beyond the control of the ESOs which cause delays and these have to be accepted. Standardisation cannot move quicker than cultural changes often needed in some sectors. The pace of standardisation will always be dependent on the acceptance and pace of implementation of the European policy which the standards support.

Management of the standardisation process is, in the first place, the responsibility of European Standards Organisations and their national members, including the respective stakeholders. It is the task of the European Standards Organisations, their members and stakeholders to improve the standardisation process continuously and to ensure effective project management. Early consideration of all the potential problems, including those that arise for reasons beyond the control of the ESOs, should become standard practice when deciding to start standardisation work in a particular area. This will assist with planning and help manage expectations.

Since the Commission's report of September 2001 and the Council Conclusions of 1 March 2002, which have taken up this issue again, the European Standards Organisations have continued to review their processes, to increase efficiency and improve consensus. A recent enquiry amongst the three European Standards Organisations has confirmed this but has also shown that the results of these efforts vary significantly which is mainly due to the very different nature of each standards organisation.

ETSI, as a standards organisation serving quicker and ever changing market needs, has started to introduce electronic working tools and is continuously striving to improve the efficiency of its processes. The standards development process is measured by the ETSI Secretariat in several ways in order to monitor the lead times in the production of all deliverable types.

CENELEC installed an audit system to assess, on the basis of defined benchmarks, the functioning of the technical bodies. These technical bodies are required to report regularly to the Technical Board with respect to their work programme, the progress of work and target dates of work items. Together with an improved IT infrastructure, these measures have led to a significant reduction in the time needed to elaborate standards.

In 1992 only 60% of electrotechnical standards were produced in under four years. However, since 1999, this percentage has increased to almost 80%. Indeed, 50% of the electrotechnical standards are now produced in less than three years time.

For CEN, in 2002, the average period for developing standards was still slightly over six years. This long development period is, compared with the other two organisations, certainly due to the specific situation that CEN has to act in all industrial sectors and that the industrial actors themselves have a great influence on the speed of the standards development. Whereas, for example, in the machinery sector standards are developed very quickly, in the construction sector it took more than 10 years until the first standard was developed.

In order to speed up standards development, CEN has established a special advisory group to the Chairman of the Technical Board. This group has established a whole set of actions in order to increase efficiency. These actions comprise: a feasibility study prior to the adoption of new work, an accelerated timeframe for the development of European Norms and the promotion of the use of New Deliverables. Moreover, CEN improved its IT infrastructure for producing and disseminating European standards, allowing it to conduct the exchange of documents electronically. If these actions are carried out, the timeframe for the development of a standard is expected to be reduced to three years.

The European Standards Organisations are invited to continue their activities and to show further substantial progress in improving efficiency. They are also invited to consider making use of a benchmarking exercise with this objective in mind.

With regard to the transposition of European standards into national standards, the National Standards Bodies are invited to undertake efforts to accelerate this task.

3. New standardisation products ("New Deliverables") and their role in European policies

The rapid development of technologies and processes in some sectors, in particular in the information and communication technology (ICT) sector, has led to an industry need for the equally rapid creation of specifications which do not have the status of a formal standard. In order to respond to this need, there has been a mushrooming of industrial fora and consortia developing such specifications. It is considered doubtful whether, in the light of the speed of development and the limited participation of experts, the fundamental principles for accountability of standardisation such as openness, consensus and transparency are followed in a robust fashion. The increasing development of new technical specifications by consortia, which operate outside of the standardisation framework and independently of standardisation principles, has to be considered as a major challenge to the current standardisation system.

The European Standards Organisations are aware of these developments. Following a request of the Council in its Resolution of October 1999, as a response, they have extended their range of deliverables beyond the formal European standard (EN) by a common portfolio of three New Deliverables (the Technical Specification (TS), the Technical Report (TR) and the Guide (G)). These incorporate fora and consortia into the system, but do not strictly follow the formal procedure for the development of European standards and are not adopted by national vote.

In addition to the above three common New Deliverables, CEN and CENELEC have developed the "CEN/CENELEC Workshop Agreement (CWA)" in their product range. Proposals for workshops may come from any interested party. Workshops originated in the ICT area, but are now expanding outside of this, and may cover any area within the scope of CEN/CENELEC's activities. Participation is open to all interested parties, including those from third countries. The usual development time for a CWA in the ICT sector is between 12 and 18 months.

With the development of these new types of documents, the European Standards Organisations are providing alternatives to face the challenge of documents developed outside the standardisation system. These alternatives may provide an appropriate response to market needs. The European Standards Organisations are encouraged to continue with this approach while reviewing with stakeholders, and in particular industry, the appropriateness of the response to their needs.

New deliverables may be used to support European legislation and policies, as it is already the case in the ICT area (see again annex 3), on a case by case basis. However, due to fact that the principles of standardisation are not always observed in a robust fashion, the decision on whether to use a new deliverable should be explored early in the process and then the final document would need to be assessed for its suitability against the policy.

4. Participation of interested parties

The acceptability of standards depends, to a large extent, on the full involvement of all relevant, interested parties. The participation of societal stakeholders [24] in the standardisation process has a strong and important dimension of accountability. It reinforces the quality of the consensus and makes the standards more representative.

[24] Those representing consumer, health, safety and environmental interests in standardisation.

However, standards development is time-consuming and costly in terms of the human and financial resources that have to be provided to achieve a meaningful input into the process. The participation of SMEs and societal stakeholders can be hampered by a lack of resources and technical expertise. This can, in turn, affect the consensus-reaching process and therefore cause delays in standards development.

4.1 Participation at ESO level

The Commission is aware of this situation and of the necessity of a broad societal stakeholder participation in standards development. It is therefore providing financial support to European organisations and associations representing SME and societal stakeholder interests. This enables them as associate members in the European Standards Organisations to participate more effectively in the standardisation process at the European level and to co-ordinate the involvement of all national experts in the standardisation development process. These stakeholders are NORMAPME [25], representing SME interests (SMEs account for more than 90% of European industry but are often not aware of how standards can be used as a strategic tool to increase competitiveness), ANEC [26] - consumer interests, TUTB [27] - worker interests, and ECOS [28] - environmental interests.

[25] http://ueapme.com/normapme

[26] http://www.anec.org/

[27] http://www.etuc.org/tutb/

[28] European Environmental Citizens Organisation for Standardisation http://www.ecostandard.org

As these groups operate at the European level, they can help to promote and co-ordinate the participation of interest groups at the national level.

4.2 Participation at NSB level

Standardisation in Europe is based on the principle of national representation. Therefore, it is primarily the task of the national members of the ESOs to ensure that all relevant, interested parties have the opportunity to contribute to the development of European standards.

An enquiry amongst the Member States has shown that the efforts of their National Standards Bodies and public authorities to ensure the representation of interest groups are highly variable. These efforts range from allocating valuable resources to doing nothing. Furthermore, within individual Member States, the efforts made for each of the different interest groups vary greatly. For example, some NSBs have allocated staff to deal specifically with consumer interests but they have no similar initiatives with respect to SMEs or environmental interests. However, all of these interests are equally important in the context of sustainable development. Therefore, efforts must be increased to ensure that European standardisation is recognised by the industrial stakeholders, particularly SMEs, as a strategic tool to raise competitiveness. Member States are invited to take further steps ensuring the proper participation of all societal stakeholders in their National Standards Bodies.

4.3 Participation of authorities in the area of harmonised standards

Finding the appropriate level of participation for public authorities in standardisation at the national level is important. On the one hand, the standardisation system needs to be allowed to work independently but, on the other hand, public authorities have detailed knowledge of the national regulatory background to a particular subject. Finding the appropriate level of participation for public authorities ensures that standards correctly translate relevant legal requirements. Therefore, early involvement in European standardisation helps to avoid safeguard clauses [29].

[29] Official procedure established under Directive 98/34 and the different sectorial New Approach Directives to object to a standard formally.

5. The shortcomings of the existing legal framework regarding standardisation in covering new developments

There has been an enormous increase in the use of standards to support European legislation and policies. Standards in the service sector have become more and more important. In addition, the range of products has been extended to a whole set of new standards documents ("New Deliverables") beyond the formal standard.

Against this background, it is doubtful whether the current legislative framework, which is mainly established by the "Directive 98/34 of the European Parliament and of the Council of 22nd June 1998 laying down a procedure for the provision of information in the fields of technical standards and regulations and of rules on information services" [30], is still sufficient to cover all of these developments and needs.

[30] OJ L 204 of 21.7.1998, OJ L 217 of 5.8.1998

Mandates are currently issued in areas beyond the Single Market for goods, e.g. ICT, worker protection, consumers, environment, services. The scope of application of the Directive 98/34 in its present version, however, only relates to "products". It should therefore be extended to services to cover the needs of today.

At the same time, it is unclear whether the new standardisation documents, which do not have the status of a formal standard, are covered by Directive 98/34. The present definition of the term "standard" in this directive is very broad and would allow the inclusion of the new standards documents into the scope of application of this Directive. As a consequence, the Commission would be permitted, in accordance with the respective provisions of the Directive, to issue mandates for new standards documents. On the other hand, however, these documents would be subject to the information procedure and the standstill/withdrawal obligations stipulated by the Directive. In this case, similar specifications developed by private fora and consortia would have greater appeal to stakeholders on grounds of flexibility of development and time to market. Therefore, a clarification of existing procedures with particular regard to new standards documents is needed.

Finally, the current legal framework does not specify which principles European Standards Organisations must observe to be recognised as being "European". In fact, a standards body is recognised as a European standards body if the principles of "openness, transparency, consensus, full participation of all stakeholders and coherence" are observed. These principles are identical with the recent Commission's proposals for "good governance" and "better regulation" and their observance is indispensable for both the accountability of European standardisation and the acceptance and legitimacy of European legislation and policies. It is evident that these principles are generally observed by the European Standards Organisations. In addition, they are explicitly set out in the new "Co-operation Guidelines", signed between the ESOs, the European Commission and EFTA [31]. However, these Guidelines are a political document and do not provide the legitimacy necessary for European standards supporting European legislation and policies. Thus, for the sake of completeness, these principles should also be clearly laid down in a legally binding act.

[31] OJ C 91 of 16.4.2003

6. Financing

In its Resolution of October 1999 and its Conclusions of 2002, the Council invited public authorities to acknowledge the strategic importance of standardisation by giving concrete expression to their commitment to it, in particular by contributing to maintaining an adequate and efficient standardisation infrastructure. It considered that whilst traditional sources of income were likely to change, standards bodies and public authorities in the Member States had to consider how the financial viability of the European standardisation infrastructure could best be preserved. The Council also confirmed its intention to continue to provide Community financial support to European standardisation within appropriate budgetary limits.

6.1 The Commission's financial contribution to the system

The Commission's financial contribution to the system in support of internal and external policies has remained stable over recent years (see annex 4). Since 1985, in order to ensure continuity in financial support provided by the Commission, the ESOs have signed framework contracts with the Commission which lay down the legal, administrative and financial terms underpinning the provision of financial support for the conduct of standardisation work. A new Framework Partnership Agreement (FPA), defining the respective roles and responsibilities of the Commission and the European Standards Organisations, for financing various standardisation activities based on five pillars (see below), has been in place since the beginning of 2004.

The five pillars of financial support to European standardisation

1. Annual performance contracts in order to improve efficiency, quality and visibility of the three European Standards Organisations through the achievement of specific tasks. The objective is to reduce the delays in standards production, to optimise the use of European standards, to raise the level of awareness of the opportunities offered by standardisation, to improve electronic working and to promote the benefits of European standardisation.

2. Quality of European standardisation: the objective is to enhance the quality of European standards used in support of EU legislation by :

- supporting translations into Community languages other than French, English and German,

- supporting consultants' activities to ensure the compliance of these ENs with the EU directives' essential requirements.

3. Support to European standardisation work (production of ENs, etc) mainly on the basis of EC mandates adopted through the 98/34 Committee procedure in support of various EU policies and legislation.

4. External visibility and promotion of the European standardisation system in the world.

5. Co-operation and technical assistance contracts managed by External Relations Directorate-Generals.

6.2 The viability of the system

Beyond the needs to support EU legislation and new policy areas, there is a strong interest for the EC to support a European standardisation system capable of avoiding barriers to trade and increasing the competitiveness of European industry for products and services.

At present, however, there is no legal act explicitly allowing for the financing of European standardisation. In order to overcome this gap, a new single basic act is needed which enables the Commission to provide financial support for all activities of European standardisation. This act must be comprehensive and take into account the increased use of standardisation in all policy areas, e.g. ICT, transport, environment and consumer protection. At the same time, the new act will need to take into account the particular needs of European standardisation.

The viability of the system also has to be considered from the point of view of the financing of Central Secretariats to ensure greater coherence and stability in the system after enlargement. The existence of efficient and stable central infrastructures is a pre-requisite for the functioning of the European standardisation system. At present, in the case of CEN and CENELEC, the financing of the central infrastructures depends exclusively on EU and EFTA funding as well as on membership fees. In comparison, the National Standards Bodies benefit from a broad direct income base for their financing including income from products and services.

The Commission considers that contributions from public authorities, (including the Commission) and National Standards Bodies are not enough to ensure the financial viability of the European system. The possibility of providing additional sources of financing for central infrastructures has to be explored with CEN and CENELEC. The presence of stakeholders' representatives in all ESOs' boards would also be a source of stability, efficiency and creativity. The Commission proposes that ESOs, in cooperation with stakeholders, explore further options to ensure the viable financing of the European standardisation system, taking into account the ways in which National Standards Bodies are funded.

Finally, in given policy areas (e.g. in the area of ICT) there may be a need for setting up pre-standard specifications to be elaborated by organisations and consortia outside the three European Standards Organisations. This may be, in particular, the case where the European Standards Organisations are not willing or able to develop European standards. The forthcoming legal basis for providing financial support to European standardisation should enable the Commission, on the basis of procedures ensuring fair competition, to provide financial support.

7. The European principles of good governance in international standardisation bodies

Within the WTO, there are a number of international standardisation organisations which produce "international standards" within the meaning of the TBT agreement, e.g. the International Maritime Organisation, or the framework of agreements and conventions for international road, rail, inland waterway, and combined transport. These "standards" are developed exclusively amongst Government representatives without direct participation of individual stakeholders to whom they are targeted. There is a potential to enhance the application of European principles of good governance and accountability. The Commission will seek to find opportunities to render the procedures and structures under which these standards are developed more open and transparent.

8. The global dimension of standardisation

Global trade continues to increase. The use of international standards can enhance market access and facilitate trade. Like most other trade blocs, Europe follows a philosophy of coherent standards identical to or based on international standards. Europe promotes, at several levels (see below), the philosophy of a coherent standards environment with accountable institutions where market players and, if needs be, authorities can rely on a single, voluntary standard supported by all interested parties.

The Commission's undertakings to promote its philosophy in standardisation

- Participation in Business Dialogues such as the Transatlantic Business Dialogue (TABD), the Mercosur-European Business Forum (MEBF) and the EU-Russia Industrialists' Round Table (EU-Russia IRT) where standardisation is among the regular topics of talks between businesses.

- Support to Co-operation and Partnership Agreements of the European Standards Organisations with the International Standards Organisations (ISO, IEC, ITU) to avoid duplication of work at the regional and international level and ensure the operation of a coherent international system (Dresden, Vienna agreements)

- Promotion of standards-receptive regulatory models such as the United Nations Economic Commission for Europe (UN/ECE), in particular its Working Party on Technical Harmonisation and Standardisation Policies, which has developed a concept similar to the New Approach and encourages governmental co-operation on essential legal requirements

- Technical assistance plays a pre-eminent role in the pursuit of the Commission's objectives regarding the promotion of its standardisation philosophy. Technical assistance is also accompanying the Community's objectives to create common economic areas with the European Union's neighbouring countries such as Russia and the countries from the Mediterranean basin.

However, in order to be in a position to do this, and to demonstrate the effectiveness of the European system, the Community needs a strong standards system at European level which is able to ensure that international standards, elaborated and transposed into European standards to support Community policies, are coherent with these policies. A diversified system based on many competing National Standards Bodies could never play such a role. Member States and their National Standards Bodies are therefore requested to continue to support a strong and coherent European standards system. At the same time, it is necessary that European industry and stakeholders are fully engaged in European standardisation so that they can be a driving force at the level of international standardisation.

The Commission will continue to promote international standards elaborated by the International Standards Organisations (ISO, IEC and ITU) and their uniform transposition in the European Union.

ANNEX 1

New EU legislation and legislative proposals supported by standards (since September 2001, the last report from the Commission on actions taken on European standardisation)

A) Areas in which new legislation supported by standards is already in place

1) The new Directive on General Product Safety [32] pursues the objective of better defining the criteria for assessing product safety and clarifies the role of European and national standards in this regard.

[32] OJ L 11 of 15.1.2002

2) The Directive on Interoperability of the trans-European conventional rail system [33] establishes the conditions to be met to achieve the interoperability of the trans-European conventional rail system. The development of a number of Technical Specifications for Interoperability (TSIs) that determine the interoperability of constituents and interfaces is required. According to this Directive, the Commission, assisted by a Committee, is entitled to decide if the harmonised standards, elaborated by the European Standards Organisations, comply with these TSIs.

[33] Directive 2001/16/EC of the European Parliament and of the Council of 19 March 2001 on the trans-European conventional rail system (OJ L110, 20/4/2001)

3) In the ICT sector, there exists a whole set of new legislation in which Europe-wide codes of conduct under the aegis of the European Standards Organisations are being used to support that legislation. Examples are

- the Directive on Data Protection [34],

[34] OJ L 281 of 23.11.1995

- the Directive on "Electronic Signatures" [35],

[35] Finalised as Directive 1999/93/EC. In this context, the Commission, on 14.7.2003, adopted a Decision, by which it published a list of generally recognised standards (workshop agreements) for electronic signature products (OJ L 175 of 15.7.2003)

- the Directive on E- invoicing, and

- the new regulatory framework for electronic communications networks and services (which consists of five Directives [36] altogether),

[36] Directive 2002/21/EC of the European Parliament and the Council of 7 March 2002 on a common regulatory framework for electronic communications networks and services (Framework Directive); Directive 2002/20/EC of the European Parliament and the Council of 7 March 2002 on the authorisation of electronic communications networks and services (Authorisation Directive); Directive 2002/19/EC of the European Parliament and the Council of 7 March 2002 on access to, and interconnection of, electronic communications networks and associated facilities (Access Directive); Directive 2002/22/EC of the European Parliament and the Council of 7 March 2002 on universal service and user's rights relating to electronic communications networks and services (Universal Service Directive); Directive 2002/58/EC of the European Parliament and the Council of 31 July 2002 on the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications

4) The Regulation relating to Fertilisers [37] aims at consolidating 18 existing Directives in order to simplify Community legislation on the harmonisation of Member States' legislation in the field of fertilisers and to ensure the free movement of these products within the European Union whilst specifying the characteristics to which they must conform. In this proposal, European standards will now design and harmonise the test methods and analyses regarding the content of different fertilising elements which, in previous legislation, were regulated in the annexes of the Directives themselves.

[37] OJ L/2003/304/ 1 (Volume 46: 21/11/2003)

5) The regulation of the European Parliament and of the Council on the interoperability of the European Air Traffic management network sets out a comprehensive approach towards standardisation as an instrument for the creation of seamless air traffic management systems in a more integrated air traffic network, and for the introduction of new technologies in the sector [38].

[38] OJL/2004/96/26

6) In the environment sector standards support the implementation of the Directive on the energy performance of buildings [39], the Directive on the promotion of the use of biofuels or other renewable fuels for transport [40] and the Directive on waste electrical and electronic equipment [41].

[39] OJ L 1 of 4.1.2003

[40] OJ L 123 of 17.5.2003

[41] OJ L 37 of 13.2.2003

7) The Regulation (EC) No 882/2004 of the European Council and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules [42] expressly refers to methods of sampling and analysis developed by CEN in case that there are no relevant Community rules.

[42] OJ L 191 of 25.5.2004

8) The Directive 2004/22/EC of the European Parliament and of the Council of 31 March 2004 on Measuring Instruments [43] uses standards to give presumption of conformity to the essential requirements of the various measuring instruments covered.

[43] OJ L 135 of 30.4.2004

B) Commission proposals for new legislation supported by standards

In the transport area, with a view of increasing the interoperability and of making the use of new containers more efficient and safer, the proposal of the Directive on Intermodal Loading Units (ILUs) [44] stipulates essential requirements and confers presumption of conformity to these requirements if harmonised standards, mandated by the Commission and elaborated by one of the European Standards Organisations, are used.

[44] Proposal for a Directive of the European Parliament and of the Council on Intermodal Loading Units (COM(2003) 155 final)

The proposal for a Directive on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields and waves) refers to standards with regard to the assessment, measurement and calculation of workers' exposure to electromagnetic fields.

A similar example which foresees the same procedures in using standards to support Community legislation is the proposal for a Community Framework Directive for Eco-design Requirements for Energy-using Products (EuP-Directive) [45] which will allow for the establishment of eco-design requirements.

[45] COM(2003)453 final (LS)

The same applies for the proposal for a Directive on Electronic Road Toll Systems [46] which aims to ensure migration towards the future interoperability of the existing different electronic toll systems.

[46] Communication from the Commission developing the trans-European transport network: Innovative funding solutions Interoperability of electronic toll collection systems. Proposal for a Directive of the European Parliament and of the Council on the widespread introduction and interoperability of Electronic road toll systems in the Community (COM(2003), 132 final)

The proposal for a new approach Directive on the placing on the market of pyrotechnical articles [47] allows the use of standards to provide the methods for testing such articles.

[47] No official document available yet

ANNEX 2

Orientations in the area of ICT standardisation

Key issues

Europe needs a standardisation structure that fits the current liberalised market. In fact, over the last decade, the marketplace has fundamentally changed and changes seem to be lasting: the liberalisation of the market which has brought competition within and between sectors; the globalisation of markets with technology developments pursued in global strategic partnerships and coalitions and a reduced role from government. But perhaps most important is the shift away from hardware to software. The monolithic world of the past has been replaced by a heterogeneous technology development and standards environment and new complex relationships between networks and business models as well as contractual and strategic business relationships - often at global level - between all key players.

- The specific challenges of ICT standardisation The current EU standardisation policy ,takes its origin from the Directive 98/34, originally Directive 83/189 which implements the Internal Market objectives. In the area of ICT, Council Decision 87/95/EC has provided a complementary reference for ICT standardisation. The EU standardisation system is based on full openness, democracy, transparency and inclusiveness. Clear IPR rules are agreed as well as national implementation of EU agreed standards. The deliverables of the ESOs' formal consensus process are the traditional ENs.

The legal framework has been effective in supporting the New Approach areas. Its adequacy to today's market conditions, however, in the ICT sector is questionable [48].

[48] The EU regulatory acts that affect ICT have internal market objectives; they are however not new Approach legislation. Moreover the policy objectives for the relevant EU legislative acts often services for which ICT solutions enact as enabler but ICT is not the prime objective of these acts: e.g. privacy, electronic signature, VAT. The EU ICT standardisation infrastructures should reflect these characteristics if the are to produce the timely and "solution driven" standards that industry/business wants. The current ESO structures, being characterized by its openness and stability, may be perceived to be ill responding.

The ICT market is in constant evolution, it is characterised by globalisation, telecommunication liberalisation, convergence between telecommunication and information technologies, and in the near future with media and broadcasting services. ICT technologies are pervasive; all industries are ICT users; subsequently the ICT standardisation community is in constant change. There is no stable community in the way that exists in traditional domains such as construction, machinery or pharmaceuticals.

- While consortia/fora standardisation is exceptional in the traditional sectors it becomes an increasing practice in the ICT sector; examples of such consortia standards are: Bluetooth, Internet, DVD, MHP, IEEE 802.11 and 802.16. All these standards have been developed outside the remit of the formal European and International Standards Organisations; often by the same industries that form the membership of the formal standards organisations. Some of these standards have been successful and reached broad market acceptance. Industry and business want standards and standardisation infrastructures to offer solution-driven standards available in time and in a flexible manner; the solution chosen by industry can range from the full formal standard, through the limited consensus for a standard, best practices, guidelines and ultimately the proprietary standard. The choice will depend on the circumstances; it is for the market to decide.

Industry should, however, not be driven outside the boundary of formal standardisation by weakness, real or perceived, of the formal standardisation structures.

- On the ICT market, the players in the new value chain have commercial incentives to achieve end-to end interoperability at the network/device interface while allowing for competitive differentiation of applications and services.

Standardisation is essential, but not sufficient to achieve network interconnection and interoperability of services at the international level. Moreover, standardisation in support of interoperability requires activities beyond traditional standardisation; such as interoperability testing, reference implementations and guidance. Standardisation in support of interoperability has developed in two different patterns:

Infrastructure standardisation: this sector is characterised by long term solutions and large investments conditioned by a priori consensus on the level of interoperability. The market is usually dominated by large players; until recently the incumbents. These requirements are resulting in open and formal standards produced by the ESOs; the infrastructure domain is conditioned by legal frameworks especially the communication framework directives.

Inversely, the IT business is characterised by short term development, fragmented market with aggressive competitors; interoperability can be met by various solutions such as gateways, API's etc. However the lack of interoperability between systems/applications and services will impede the collaboration between business, prevent emergence of new e-services and facilitate the dominance of proprietary solutions, thus undermining a long-term competitive market.

Efficiently and timely responding to these different patterns will require the ESO's to reflect the differences in their structures and processes.

- When bringing innovative technology solutions or new services to the market industry seeks prior standardisation amongst partners. The standardisation effort covers interoperability aspects, other technical issues but may also cover more commercial aspects. The standardisation effort should be flexible and be able to quickly evolve in response to market requirements. Therefore, industry often prefers to perform this type of standardisation in support of innovation within an industry consortium; it is less open but there exists a commitment to implement and a restricted IPR policy. At a later stage, probably when the return on investment related to the innovation phase has been recovered, industry would agree to bring the fora standardisation into the public domain; the consensus reached within the fora can be broadened through formal standardisation bodies.

- In the ICT domain, the link between R&D and standardisation is of particular importance; standardisation is in a position to leverage the consensus reached within an R&D project at the European and/or international level, thus the results of EU research will subsequently be consolidated. Due to the complexity of the issue, the high technical expertise required in a particular domain, the fast technological evolution and the specialised user community, formal standardisation may however not be an option; more restricted groupings would certainly have an advantage. In addition, the formal standardisation process, especially ex-ante standardisation efforts, would benefit from targeted R&D initiatives to speed up the standardisation work. Projects such as COPRAS (standardisation liaison for the 6th framework programme) should be further promoted.

The increasing use of fora/consortia infrastructure by industry will be challenging for the ESOs in their actual structures and processes. This impacts on the role of the public authority. The Commission's interest in ICT standardisation can be described in following categories:

- Standardisation in support of regulation/legislation: internal market or not, and new approach legislation or different types of legislation. Whilst the Internal Market/New Approach situation is precisely defined (e.g. the current legal basis for standardisation provided by Directive 98/34) the situation is less evident for the case of ICT. As ultimately national public authorities will need to provide legal recognition for the standardisation deliverables in view of compliance with the legal frameworks, a reflection should be initiated on how standardisation can be used in support of these legal frameworks, taking into account the specificities of the ICT market. The possible role of consortia/fora standardisation: the possible co-operation or integration with the ESOs in this particular case should be evaluated against the need for openness, democracy, inclusiveness etc as required for standards aiming at this particular use.

- Standardisation in support of EU policies in the ICT area, not being embedded in legal frameworks: in this particular case, public authorities are interested in the provision of transparent, open and democratic platforms for consensus building which allow all relevant stakeholders to participate. The main aim is to achieve the objectives set by the policies with the support of standardisation while taking into account public interest aspects. Also for this particular use of standardisation deliverables, the co-operation with consortia and fora, the specific process and rules; an in depth reflection should be initiated.

- Standardisation in support the competitiveness of EU industry: should in principle be in accordance with the EU competition policy. Public authorities should not be involved in this domain. It is, however, important that open, neutral and accessible platforms are provided for reaching consensus.

Possible follow-up:

The changed environment for ICT standardisation should be reflected in a reorientation of the EU standardisation policy and the role of the ESOs; The formal ESOs can play a major part in a more integrated process provided following issues are taken care of:

- Provide international representation

- Have a flexible and more integrated approach that ensures timely development of standards, or additional standards-related documents, that are responsive to the specific needs of industry and do not inhibit innovation. This could be achieved through increased fora hosting as proposed at the ETSI GA , or through a more elaborated co-operation with fora and consortia at the ICT-SB level

- A more efficient implementation of the convergence aspects, as the current rather historical work repartition between the ESOs is confusing for business and industry.

- Disseminate and promote the adoption of those standards that are needed by industry.

- Develop an integrated standardisation policy including better liaisons with R&D, collaborative initiatives, clarification of legal aspects, IPR policy, interoperability aspects and international dimensions as well as a better support towards implementation of standards notably via public procurement.

ANNEX 3

The eEurope Standardisation Action Plan (challenges and results)

The Commission has supported this standardisation initiative in the years 2000-2002 with an overall budget of 12,5 MEUR. For the years 2003-2005, further financial support will be provided.

As a result of the eEurope Standardisation Action Plan, some very good results have been achieved which have strengthened the role of European ICT standardisation as a platform for industrial consensus building. However, still more needs to be done to improving the visibility of standardisation in support of the eEurope initiative and to disseminate the results better. In this respect, the free availability of eEurope standardisation deliverables has proved to be a factor for success.

The results of the eEurope Standardisation Action Plan will be carefully analysed and evaluated by the Commission's services in order to prepare for a conceptual framework within which clear targets and performance indicators for funded standardisation work in support of the eEurope initiative will be set. This requires, however, a more intensive dialogue with Member States and the relevant stakeholders as well as enhanced efforts to promote the practical use standards in support of eEurope.

In the field of ICT standardisation, interoperability is the most important challenge to reach the target of the eEurope 2005 Action Plan of "interoperable e-business solutions for transactions, security, signatures, procurement and payment". As described in the Communication on "Adapting e-business policies in a changing environment", it is primarily the responsibility of the private sector to implement this ambitious task. However, European, national and regional authorities can play an important role in bringing together the different economic players and promoting e-business interoperability through large scale test-beds. In order to avoid further fragmentation and to facilitate cross-border electronic transactions, the many standardisation initiatives in this field need, however, to be much better co-ordinated at European level than is currently the case.

ANNEX 4

The financial support to European standardisation in figures

Summary of commitments made in 1998 - 2004

The overall allocation of commitments 1998 - 2004 (in million euros)

(The financial support was provided from the budget line B5-3130B between 1998 and 2003 and from B5-3140B between 1998 and 2000. Other support given from other budget lines has not been included. In 2004 the standardisation budget line is called 02 04 03.)

Year // Amount committed

1998 // 20,9

1999 // 19,9

2000 // 16,7

2001 // 16,1

2002 // 16,0

2003 // 14,8

2004 (estimated) // 18,7

The repartition of financial support in different fields, commitments made in 2000 - 2004 (in million euros)

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