This report analyses the application of the procedures laid down by Directive 98/34/EC from 2011 to 2013 as regards technical regulations and for 2011 and 2012 as regards standards. It highlights the important contribution of the notification procedure to the functioning of the single market and to the implementation of the Better Regulation policy.

1 ) Standardisation : the report describes the operation of the standardisation part of Directive 98/34/EC covering three main activities: (i) the information procedure on standards, (ii) Commission requests to the European Standards Organisations for standardisation work (mandates), and formal objections against standards supporting New Approach Directives. Statistics cover the period 2011-2012, as the standardisation part of Directive 98/34/EC was repealed as of 1 January 2013 by Regulation (EU) No 1025/2012 on European standardisation.

- Information procedure : the information procedure still plays an important role in encouraging national standardisation bodies to bring their initiatives to the European level, thus encouraging the single market and European harmonisation. Notifications from EU 12 Member States are stable which can be considered as a good sign of their integration in the system.

The number of notifications made by the EU27 countries continued to be stable with between 1750 and 2000 notifications per year. The construction sector continues to dominate the national notifications in CEN, followed by food products and petroleum products. In CENELEC, electrical accessories, electric cables, and electrical installations in buildings have been significant subsectors.

- Mandates : the report notes that the process of mandating is well established and is today governed by Regulation (EU) No 1025/2012. The informal consultation of the ESOs and all interested parties (in particular those European stakeholders representing the users of future standards) prior to the consultation of the Committee on Standards and Technical Regulations is essential.

To improve transparency, the Commission services continued in the reporting period in the practice introduced in 2006 to invite the European standardisation stakeholders ANEC, ECOS, ETUIREHS and NORMAPME, to participate in its enlarged meeting.

The Commission considers that the process of mandating has proved to be instrumental in enlarging the role of standardisation in new areas of EU legislation and policy . Mandates supporting Directive 2009/125/EC (the Ecodesign Directive), aimed at products such as household dishwashers, lamps, air conditioners, pumps or fans, have been a major contributor in increasing the number of mandates.

- Formal objections : the procedure in general has worked adequately . Compared to the previous reporting period, the process from receiving the objection to issuing the Decision was shortened significantly in 2011 and 2012.

In a similar way to the mandates, and for the sake of transparency, the Commission makes decisions on formal objections public in a consolidated way, and makes an updated table of the actions in relation to the formal objections available to the Committee on Standards and Technical Regulations at each meeting.

2) Technical regulations : the 98/34 notification procedure for national technical regulations allows the Commission and the Member States of the EU to examine preventively the technical regulations Member States intend to introduce for products (industrial, agricultural and fishery) and for Information Society services.

From 2011 to 2013, the Commission received 2114 notifications (675 in 2011, 734 in 2012 and 705 in 2013). As in the previous reporting period, the construction sector saw the highest number of notifications over the reporting period, with many measures relating to energy efficiency of buildings and concrete structures, road pavements and constituent materials, fire safety of buildings. Agricultural products, foodstuffs and beverages again followed construction, whilst notifications increased in the telecommunications and in the environment sectors.

The report concludes that during the period 2011-2013, the usefulness of the procedure has again been confirmed in terms of effectiveness, transparency and administrative cooperation.

The Commission considers that the preventive and networking approach of the 98/34 procedure has substantially reduced the risk of national regulatory activities being carried out in a way that would create technical barriers to the free movement of goods within the internal market. The 98/34 procedure has also confirmed its usefulness in providing the possibility to identify areas where harmonisation at EU level might be an option.

When applying Directive 98/34/EC the Commission remains vigilant regarding the principle of better regulation and the need to sustain a favourable environment for the competitiveness of the European economy. Notified drafts continue to be available electronically, free of charge and in all the official languages of the EU, thus providing the opportunity for economic operators and other stakeholders to comment on them.

Efforts will continue in order to ensure a clear legal framework for economic operators aiming at enhancing the competitiveness of European enterprises in the EU and abroad.

In its resolution of 15 January 2014 entitled ‘Reindustrialising Europe to promote competitiveness and sustainability’, the European Parliament encouraged further exploitation of the potential of the 98/34 notification procedure.

COM(2015)0338
EUR-Lex

EUR-Lex
SWD(2015)0137

The Commission presents a report analysing the application in 2009 and 2010 of the procedures laid down by Directive 98/34/EC for standardisation and technical regulations. It highlights the important contribution of standardisation and of the notification procedure for technical regulations to the functioning of the single market and to the implementation of the “Better Regulation” policy.

Standardisation: the report describes the operation of the standardisation part of Directive 98/34/EC covering three main activities: the information procedure on standards, Commission requests to the European Standards Organisations for standardisation work (mandates) and formal objections against standards supporting New Approach Directives. It provides explained statistics for the period 2009-2010.

Information procedure : the Commission states that the information procedure still plays an important role in encouraging national standardisation bodies to bring their initiatives to European level, thus encouraging the single market and European harmonisation. Notifications from new Member States are stable which can be considered as a good sign of their integration in the system.

Mandates: the report states that the process of mandating is well-established, but care must be taken to ensure it continues to operate smoothly. To this end, the informal consultation of the ESOs and all interested parties, in particular those European stakeholders representing the users of future standards, prior to the Committee consultation is essential and should continue.

To improve transparency in the functioning of the Committee, the Commission services have invited the European standardisation stakeholders, ANEC, ECOS, ETUI-REHS and NORMAPME, to participate in its enlarged meeting.

For the sake of transparency, and thanks to the technological advantages that will be incorporated into the CIRCA10 system, the services of the Commission will in future consider the possibility of organising a written procedure inspired by internet forums . The objective will be to ensure that all committee members can read the observations of the other members, rendering this type of consultation similar to that held at the Committee meeting.

The process of mandating has proved to be instrumental in enlarging the role of standardisation in new areas of EU legislation and policy. This is also reflected by the fact that a number of new EU legislative acts refer to the Directive.

To enable wider and more effective use of mandates as a policy tool, the mandating process should be more responsive – the ESOs should respond earlier if requested European standards are market relevant, if they accept a mandate and on which conditions they accept it. Therefore, future modifications to the mandating process should make sure that clear deadlines are set for replies of the ESOs so that the Commission services have time to develop alternative solutions if the ESOs are unable or unwilling to develop European standards.

Formal decisions: although the process from receiving the objection to issuing of the Decision is quite time- consuming, the procedure in general has worked adequately.

In a similar way to the mandates, and for the sake of transparency, the Commission makes decisions on formal objections public in a consolidated way, and makes an updated table of the actions in relation to the formal objections available to the Committee at each meeting.

Technical Regulations

The notification procedure for national technical regulations allows the Commission and the Member States of the EU to examine preventively the technical regulations Member States intend to introduce for products (industrial, agricultural and fishery) and for Information Society services

During 2009 and 2010, the utility of the procedure has again been confirmed in terms of effectiveness, transparency and administrative cooperation.

The preventive and networking approach of the 98/34 procedure has ensured that national regulatory activities have been carried out without creating technical barriers to trade and that European Union harmonisation has occurred only where really needed, in strict compliance with the subsidiarity principle. The fact that the number of infringement proceedings remained low during the reporting period shows that Directive 98/34/EC is an important tool for ensuring the correct application of European Union legislation.

When applying Directive 98/34/EC the Commission remains vigilant regarding the principle of better regulation and the need to sustain a favourable environment for the competitiveness of the European economy. Notified drafts continue to be available electronically, free of charge and in all the official languages of the EU, thus providing the opportunity for economic operators to comment on them.

Efforts will continue in order to ensure a clear legal framework for economic operators aiming at enhancing the competitiveness of European enterprises in the EU and abroad, taking into account the links between the 98/34 procedure and that established by the Agreement on Technical Barriers to Trade (TBT) in the context of the World Trade Organisation (WTO).

COM(2011)0853
EUR-Lex

SEC(2011)1509
EUR-Lex

The Commission presents its report analysing the application between 2006 and 2008 of the procedures laid down by Directive 98/34/EC for standardisation and technical regulations. It highlights their important contribution to the implementation of better regulation and to the functioning of the single market.

1) Standardisation: this consists of the information procedure on standards, Commission requests to the European Standards Organisations (ESOs) for standardisation work (“mandates”) and formal objections against standards. They have proved to be an important element in the functioning of the single market. The information procedure has brought transparency in standards and has encouraged National Standards Bodies (NSBs) to continue to take initiatives to promote European harmonisation. Formal objections have enabled Member States and the Commission to ensure that standards meet the goals of regulation when used for the purposes of “New Approach” legislation. Mandates have provided the means by which the relationship between the Commission services and standardisers is determined: the interface between the policy level and its technical expression.

· On the information procedure , the report notes that the procedure still plays an important role in encouraging national standardisation bodies to bring their initiatives to European level. Enlargement has led to an increase in notifications from new Member States, which will stabilise and even fall as they become more fully integrated, thus following the trend led by older Member States.

· With regard to mandates, the report states that the process of mandating is well-established, but care must be taken to ensure it continues to operate smoothly. To this end, the informal consultation of all the relevant parties prior to the Committee consultation is essential and should continue. To improve transparency in the functioning of the Committee, the Commission services have from 2006 invited the European standardisation stakeholders, ANEC, ECOS, ETUI and NORMAPME, to participate in its enlarged meeting. The process of mandating has proved to be instrumental in enlarging the role of standardisation in new areas of EU legislation and policy. This is also reflected by the fact that a number of new EU legislative acts refer to the Directive.

· With regard to formal objections , although the process from receiving the objection to issuing of the Decision is time-consuming, the procedure in general has worked adequately. In a similar way to the mandates, and for the sake of transparency, the Commission will make decisions on formal objections public in a consolidated way, and make available an updated table of the actions in relation to the formal objections to the Committee at each meeting.

2) Technical regulations : the notification procedure allows the Commission and Member States to examine preventively the technical regulations Member States intend to introduce for products (industrial, agricultural and fishery) and for Information Society services. The notification to the Commission of national technical regulations prior to their adoption has proved to be an effective instrument of prevention of barriers to trade and of cooperation between the Commission and the Member States and among the Member States themselves as well as improving the regulatory framework. Between 2006 and 2008, the utility of the procedure has been fully confirmed in terms of effectiveness, transparency and administrative cooperation. The fact that, in relation to the number of technical draft regulations notified, the number of infringement proceedings remains minimal shows that the correct application of Community legislation can be ensured through a preventive approach and the close partnership between the Commission and the Member States as well as between the Member States themselves.

This networking approach and the high degree of cooperation between the Commission and the Member States have also ensured that national regulatory activities have been carried out without creating technical barriers to trade and that Community harmonisation has occurred only where really needed, in strict compliance with the subsidiarity principle. At the same time, in certain areas where harmonisation measures already exist, the procedure has allowed to detect the need to supplement or reinforce them.

When applying the Directive the Commission will remain vigilant as regards the principles of better regulation and the need to sustain a favourable environment for the competitiveness of the European economy. Therefore notified drafts continue to be available electronically, free of charge and in all the official languages of the EU. Moreover efforts will continue to provide economic operators with a legal framework that is as clear as possible, will continue to seek to avoid "goldplating" and provide with comments, aiming at enhancing the competitiveness of European enterprises in the EU and abroad, taking into account the links between this procedure and that established by the Agreement on technical barriers to trade (TBT) in the context of the World Trade Organisation (WTO).

COM(2009)0690
EUR-Lex

SEC(2009)1704
EUR-Lex

The purpose of this Report is to analyse the application of procedures as laid down by Directive 98/34/EC for standardisation and technical regulation between 2002 and 2005. It is divided into two parts. The first deals with “Standardisation”; the second “Technical Regulations”.

Standardisation: The procedure in the field of standards has been designed to monitor all new standardisation activities introduced by the National Standardisation Bodies or NSBs. Systems have been set up to allow the bodies to comment, participate or to request an initiative be taken at European level. The report finds that the procedure has continued to operate successfully between 2002 and 2005. The publication of national standardisation initiatives encourages all stakeholders to consider the possibility of extending work at a European level. In the new field of standardising services the number of national initiatives notified is high.

Concerning Mandates the report finds that the process of mandating is well-established but care must be taken to ensure it continues to operate smoothly. To that end, the informal consultation of all relevant parties prior to the Committee consultation is essential and will need to be reinforced. As far as “Formal Objections” are concerned the report finds that the number of objections has been low. However, when taking account of new objections, the number of formal objections is on the rise. The main areas concern machinery, toys, construction products and medical devices. Although time consuming the process of receiving objections has, in general, worked well.

Technical Regulations: Between 2002 and 2005, the utility procedure has been fully confirmed in terms of effectiveness, transparency and administrative co-operation. Moreover, the high number of draft technical regulations notified by the Member States, in accordance with the Directive, contributes towards the correct application of Community legislation through a preventative approach. The networking approach and the high degree of co-operation between the Commission and Member States have also ensured that national regulatory activities have been carried out without creating technical barriers to trade and that Community harmonisation has occurred only where really needed.

The intense work undertaken to ensure that the 10 applicant countries comply with the obligations arising from the Directive on their accession to the EU has helped ensure the correct operation of the enlarged internal market.

Extending the enterprise policy dimension remains a high priority. Notified drafts are already available electronically, free of charge and in all the official languages of the EU. Efforts will continue to provide economic operators with a legal framework that is as clear as possible without any regulatory excesses.

COM(2007)0125
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COM(2003)0200
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COM(2003)0069
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COM(2000)0429

Directive 1998/34
OJ L 204 21.07.1998, p. 0037

OJ C 152 18.05.1998, p. 0014-0030
T4-0226/1998

T4-0226/1998

EUR-Lex
SEC(1998)0396

12081/1/1997
OJ C 110 08.04.1998, p. 0001

12081/1/1997

OJ C 304 06.10.1997, p. 0075-0079
T4-0437/1997

T4-0437/1997

CES0225/1997
OJ C 133 28.04.1997, p. 0005

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OJ C 078 12.03.1997, p. 0004
COM(1996)0642

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COM(1996)0642