2011/0150(COD)
European standardisation
European standardisation 2011/0150(COD)
Lead committee dossier: IMCO/7/06240
Legal basis: TFEU TFEU 114-p1
| EMPL | ENVI | IMCO | INTA | ITRE | |
| Lead Rapporteur | COMI Lara (EPP) | ||||
| Opinion Rapporteur(s) | PROUST Franck (EPP) | GIEREK Adam (S&D) |
Legal basis: TFEU TFEU 114-p1
Procedure completed
2011/0150(COD) European standardisation
Lead committee dossier: IMCO/7/06240
Legal Basis TFEU TFEU 114-p1
| Role | Committee | Rapporteur | Shadows |
|---|---|---|---|
| Opinion | EMPL | ||
| Opinion | ENVI | ||
| Lead | IMCO | COMI Lara (EPP) | SCHALDEMOSE Christel (S&D), MANDERS Toine (ALDE), RÜHLE Heide (Verts/ALE), KOŽUŠNÍK Edvard (ECR), DE JONG Cornelis (GUE/NGL), SALVINI Matteo (EFD) |
| Opinion | INTA | PROUST Franck (EPP) | |
| Opinion | ITRE | GIEREK Adam (S&D) |
Legal Basis TFEU TFEU 114-p1
Activites
- 2012/11/14 Final act published in Official Journal
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2012/10/25
Final act signed
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2012/10/25
End of procedure in Parliament
- #3188
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2012/10/04
Council Meeting
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2012/10/04
Act adopted by Council after Parliament's 1st reading
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2012/09/18
CSL Final Agreement
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2012/09/11
Text adopted by Parliament, 1st reading/single reading
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T7-0311/2012
summary
The European Parliament adopted by 639 votes to 18 with 17 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council on European Standardisation and amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/105/EC and 2009/23/EC of the European Parliament and of the Council. Parliament adopted its position in first reading following the ordinary legislative procedure. The amendments adopted in plenary are the result of a compromise negotiated between Parliament and Council. They amend the Commission proposal as follows: Objectives: the compromise text stipulates that the Regulation aims to ensure: (i) the effectiveness and efficiency of standards and standardisation as policy tools for the Union through cooperation between European standardisation organisations, national standardisation bodies, Member States and the Commission; (ii) the establishment of European standards and European standardisation deliverables for products and for services in support of Union legislation and policies, (iii) the identification of ICT technical specifications eligible for referencing, (iv) the financing of European standardisation and (v)stakeholder participation in European standardisation. European standard: the text clarifies that the term means a technical specification, adopted by a recognised standardisation body. Technical specification: the characteristics required of a product include levels of environmental protection and public health. Transparency of work programmes of standardisation bodies: during the preparation of a harmonised standard or after its approval, national standardisation bodies shall not take any action which could prejudice the harmonisation intended and, in particular, shall not publish in the field in question a new or revised national standard which is not completely in line with an existing harmonised standard. After publication of a new harmonised standard, all conflicting national standards shall be withdrawn within a reasonable deadline. When a national standardisation body receives comments indicating that the draft standard would have a negative impact on the internal market, it shall consult the European standardisation organisations and the Commission before adopting it. Participation and balanced representation of stakeholders: European standardisation organisations shall encourage and facilitate an appropriate representation and effective participation of all relevant stakeholders, including SMEs, consumer organisations and environmental and social stakeholders in their standardisation activities. Access of SMEs to standards: the compromise text introduces a series of amendments, which aim to encourage and facilitate the access of SMEs to standards and standards development processes in order to reach a higher level of participation in the standardisation system. National standardisation bodies shall exchange best practices aiming to enhance the participation of SMEs in standardisation activities. Participation of public authorities in European standardisation: Member States shall, where appropriate, encourage participation of public authorities, including market surveillance authorities, in national standardisation activities aimed at the development or revision of standards requested by the Commission. Cooperation with research facilities: the Commission's research facilities shall contribute to the preparation of the annual Union work programme for European standardisation and provide European standardisation organisations with scientific input, in their areas of expertise, to ensure that European standards take into account economic competitiveness and societal needs such as environmental sustainability and safety and security concerns. Formal objections to harmonised standards: as the European Parliament is on an equal footing with the Council in the ordinary legislative procedure, the European Parliament must have the right to object to a harmonised standard. Notification of stakeholder organisations: the Commission shall establish a notification system for all stakeholders, including European standardisation organisations and European stakeholder organisations receiving Union financing in accordance with this Regulation in order to ensure proper consultation and market relevance prior to: (i) adopting the annual Union work programme for European standardisation; (ii) adopting standardisation requests; (iii) taking a decision on formal objections to harmonised standards. Identification of ICT technical specifications eligible for referencing: either on proposal from a Member State or on its own initiative the Commission may decide to identify ICT technical specifications that are not national, European or international standards, but meet the requirements set out in Annex II, which may be referenced, primarily to enable interoperability, in public procurement. Delegated acts: the Commission shall be empowered to adopt delegated acts concerning amendments to the Annexes, in order to: (i) update the list of European standardisation organisations set out in Annex I to take into account changes in their name or structure; (ii) adapt the criteria for European stakeholder organisations set out in Annex III to this Regulation to further developments as regards their non-profit making nature and representativeness. The power to adopt delegated acts shall be conferred on the Commission for a period of five years from 1 January 2013 (which may be tacitly extended for an identical period). Review: 2 years after the date of entry into force of the Regulation, the Commission shall evaluate the impact of the procedure established by Article 10 of the Regulation on the timeframe for issuing standardisation requests. It shall present its conclusions in a report to the European Parliament and to the Council. Where appropriate, that report shall be accompanied by a legislative proposal to amend the Regulation.
- Results of vote in Parliament
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T7-0311/2012
summary
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2012/09/10
Debate in Parliament
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2012/05/07
Committee report tabled for plenary, 1st reading/single reading
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A7-0069/2012
summary
The Committee on the Internal Market and Consumer Protection adopted the report by Lara COMI (PPE, IT) on the proposal for a regulation of the European Parliament and of the Council on European Standardisation and amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/105/EC and 2009/23/EC of the European Parliament and of the Council. The committee recommends that the European Parliaments position in first reading following the ordinary legislative procedure should amend the Commission proposal as follows: European standards: Members specify that this means a standard adopted by one of the European Standardisation Organisations, which shall be implemented through its publication as an identical national standard, with the obligation for National Standardisation Organisations to withdraw any existing and conflicting national standards. Technical specification: the characteristics required of a product include levels of environmental protection and public health. Participation and balanced representation of stakeholders: Members want European Standardisation Organisations to encourage and facilitate appropriate representation and participation of all relevant stakeholders, such as public authorities, including market surveillance authorities, SMEs, organisations representing the interests of consumers, including people with disabilities, environmental and social stakeholders, including social partners, in particular, through the stakeholder organisations, referred to in Annex III, at the policy development level and at least at the certain stages of the development of European standards or European standardisation deliverables. Access of SMEs to standards: the report stresses SMEs participation in the standardisation process is essential for technological progress in the Union. It makes a series of amendments to encourage SME participation in standardization activities, particularly at national level and to facilitate their effective access to standards. It provides that National Standardisation Organisations shall exchange best practices aiming to enhance the participation of SMEs in standardisation activities and to increase and facilitate the use of standards. Ensuring the participation of public authorities: noting that in most Member States public authorities show a limited interest in participating in the standards development process, Members want the Regulation to ensure that public authorities take part in all national technical committees mirroring the development of standards mandated by the Commission. The participation of national authorities is particularly crucial for the proper functioning of legislation in the areas covered by the New Approach, and for the avoidance of ex-post objections to harmonised standards. Objection to harmonised standard: as the European Parliament is on an equal footing with the Council in the ordinary legislative procedure, the European Parliament must have the right to object to a harmonised standard. Recognition and use of technical specifications in the field of ICT: the Union should encourage contact between standardisation bodies and forums and consortia drafting technical specifications especially in the field of information and communication technologies (ICT), while avoiding the creation of a system which competes with standardisation. Either on proposal from a Member State or on its own initiative the Commission may decide, after consultation with the European Standardisation Organisations and all relevant stakeholders, including the European multi-stakeholder platform on ICT standardisation as set up by the Commission, to reference ICT technical specifications which are not national, European or international standards and meet the requirements set out in Annex II. The report supports the introduction of a new system allowing the use, in particular in the field of public procurement, of specifications developed by other organisations. Improving and accelerating the European standard-setting process through more transparency and consultation: Members consider that it is essential for European standards to be developed within a reasonable period of time. Before issuing a request, the Commission shall within a reasonable deadline consult the European Standardisation Organisations, all relevant stakeholders, especially those referred to in Annex III, and the committees of national experts set up by the corresponding sectoral directive where such a directive exists as well as notify all interested parties registered in the European Transparency register. As standards are primarily a market tool, it is necessary to ensure a high level of cooperation between the European Standardisation Organisations and the Commission in the establishment of its annual European standardisation work programme in order to ensure that the standards that the Commission intends to request from the European Standardisation Organisations are market-driven. Better consultation between the Commission and the European Standardisation Organisations is also necessary prior to the issue of a request for new standardisation work. Accordingly, the committee within the meaning of Regulation (EU) No 182/2011 shall meet at least twice per year with the European and National Standardisation Organisations. Furthermore, the Commission may invite the organisations referred to in Annexes I, Ia and III, and other relevant stakeholders, as observers, to the meetings of the committee. Joint Research Centre: the Commission's Joint Research Centre shall contribute to the preparation of the European standardization work programme and participate in the activities of the European Standardisation Organisations providing scientific input, in its areas of expertise, to ensure that standards take into account economic competitiveness and social needs such as environmental sustainability and safety and security concerns. Use of ICT: in order to accelerate the standardisation process and facilitate the participation of all interested parties in that process, European and National Standardisation Organisations should make best use, in their working methods, of information and communication technologies. Review: the Commission shall consider the need for additional measures to simplify the financing of European standardisation and reduce the administrative burden for the European Standardisation Organisations. It shall present its conclusions in a report to be submitted to the European Parliament and to the Council by 1 January 2015, and shall submit, if appropriate, a legislative proposal for the amendment of this Regulation.
- EMPL
- ENVI
- IMCO IMCO/7/06240 COMI Lara EPP
- INTA PROUST Franck EPP
- ITRE GIEREK Adam S&D
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A7-0069/2012
summary
- 2012/03/21 Vote in committee, 1st reading/single reading
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2012/03/20
Prev Adopt in Cte
- 2012/02/29 Amendments tabled in committee
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2012/02/07
Deadline Amendments
- 2012/01/04 Committee draft report
- #3133
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2011/12/05
Council Meeting
- #3113
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2011/09/29
Council Meeting
- 2011/06/23 Committee referral announced in Parliament, 1st reading/single reading
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2011/06/01
EP officialisation
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2011/06/01
Legislative proposal
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COM(2011)0315
summary
PURPOSE: to define the general framework for European Standardisation. PROPOSED ACT: Regulation of the European Parliament and of the Council. BACKGROUND: standards and standardisation are very effective policy tools for the EU. They are used as policy instruments to ensure, inter alia, the functioning of the single market of products, the interoperability of networks and systems, in particular in the field of ICT, a high level of consumer and environmental protection, and more innovation and social inclusion. This proposal addresses three major problems: 1. In a rapidly changing world and society, especially in sectors characterised by very short product lives and development cycles, standards must keep pace with rapid technological development. Some stakeholders argue that the entire process of creating European standards developed at the request of the Commission is too slow. 2. SMEs encounter a series of problems with respect to standards and standardisation. One of the most important problems, according to many stakeholders, is that SMEs are in general under-represented in standardisation activities, in particular at European level. 3. In the field of ICT, many standards ensuring interoperability are not elaborated by the ESOs but by other organisations that develop standards (hereinafter "global fora and consortia"). Concrete examples are Internet and World Wide Web related standards. At the moment, referring to "Fora and Consortia Standards" in public procurement which is subject to Directive 2004/18/CE is only possible in exceptional circumstances. To respond rapidly to evolving needs in all areas, a comprehensive, inclusive, efficient and technically up-to-date European standardisation system will be required. In its Europe 2020 strategy for smart, sustainable and inclusive growth, the Commission highlighted the necessity to improve the method of standard setting and the use of standards in Europe. On 21 October 2010, the European Parliament adopted a report on the future of European standardisation which indicated that the review of European standardisation should preserve its many successful elements, remedy its deficiencies and strike the right balance between the European, national and international dimensions. In its communication of 13 April 2011 on the 'Single market Act: Twelve levers to boost growth and confidence', the Commission included among its twelve key priority actions to be adopted by the EU institutions before the end of 2012 the extension of the European standardisation system to services. IMPACT ASSESSMENT: the Commission accepted a combination of different options: Options 1.A (deadlines on the delivery of European standards) and 1.C (transparent and simplified procedures for harmonised standards and other European standards requested by the Commission), Option 2.C (strengthen the position of organisations representing SMEs and societal stakeholders within the ESOs by providing for the possibility of an operating grant) and 3.B (referencing of "Fora and Consortia Standards" in public procurement) meet the criteria of effectiveness, efficiency and consistency. Therefore, these 4 options constitute the basis of this proposal. LEGAL BASIS: Article 114 of the Treaty on the Functioning of the European Union (TFEU). CONTENT: this proposal replaces a part of Directive 98/34/EC and repeals Decisions No 1673/2006/EC and 87/95/EEC. It aims to establish rules with regard to: (i) the cooperation between European standardisation bodies, national standardisation bodies and the Commission; (ii) the establishment of European standards and European standardisation deliverables for products and for services in support of Union legislation and policies; (iii) the recognition of technical specifications in the field of information and communication technologies (ICT) and; (iv) financing of European standardisation. The main elements of the proposal are as follows: Enhanced cooperation: the cooperation between national standardisation bodies will become more transparent. International standards: the use of standards developed by other organisations in the field of information and communication technologies will be possible in public procurement, provided that these standards comply with a set of criteria based on the WTO principles for international standardisation processes, in domains where there are no European standards, where European standards have not gained market uptake or where these standards have become obsolete. Planning: the planning will be improved: the Commission will establish an annual Work Programme, which will identify priorities for European standardisation and the mandates required. Representation of SMEs: SMEs and societal stakeholders should be better represented in European standardisation, and the financial support to organisations representing SMEs and societal stakeholders will be ensured. Simplification: a reduction of the administrative burden imposed on the Commission and the ESOs, for example by the possibility of a robust simplification of lump sums, clearly disconnected from any verification of actual costs of implementation. This proposal constitutes a further shift towards a performance-based system, based on the definition of agreed indicators and objectives (outputs and outcomes). Service standards: although European standards are already widely used for transport and logistics, postal services and electronic communications networks and services, the voluntary European standards have played a less prominent role in supporting the completion of the single market for services. This proposal therefore includes service standards within its scope in order to enable the Commission to issue mandates requesting the development of European service standards and to finance a part of the cost of this development. BUDGETARY IMPLICATIONS: the proposal relates to the extension of an existing action. It should be noted that the amounts set out in this legislative financial statement do not prejudice the forthcoming Commission proposal for the post-2013 multi-annual financial framework. Budgetary appropriations allocated to this action will be proposed by the Commission in the annual budgetary procedure. Consequently, this financial statement is limited to one year (2013). The implication on operational appropriations is estimated at EUR 27 million in commitment appropriations. DELEGATED ACTS: this proposal contains provisions to empower the Commission to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union.
- SEC(2011)0672
- DG {u'url': u'http://ec.europa.eu/dgs/economy_finance/index_en.htm', u'title': u'Economic and Financial Affairs'}, REHN Olli
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COM(2011)0315
summary
Documents
- Legislative proposal published: COM(2011)0315
- Document attached to the procedure: SEC(2011)0672
- Committee draft report: PE478.420
- Amendments tabled in committee: PE480.857
- Committee report tabled for plenary, 1st reading/single reading: A7-0069/2012
- Decision by Parliament, 1st reading/single reading: T7-0311/2012
- Results of vote in Parliament: Results of vote in Parliament
- : Regulation 2012/1025
- : OJ L 316 14.11.2012, p. 0012
Votes
A7-0069/2012 - Lara Comi - Résolution législative
2012/09/11
| Position | Total | ALDE | ECR | EFD | GUE/NGL | NI | PPE | S&D | Verts/ALE | correctional |
| For | 639 | 76 | 47 | 18 | 26 | 9 | 240 | 171 | 52 | 1 |
| Against | 18 | 0 | 0 | 11 | 2 | 5 | 0 | 0 | 0 | 0 |
| Abstain | 17 | 0 | 1 | 0 | 5 | 10 | 1 | 0 | 0 | 0 |
A7-0069/2012 - Lara Comi - Legislative resolution
2012/09/11
| Position | Total | ALDE | ECR | EFD | GUE/NGL | NI | PPE | S&D | Verts/ALE | correctional |
| For | 639 | 76 | 47 | 18 | 26 | 9 | 240 | 171 | 52 | 1 |
| Against | 18 | 0 | 0 | 11 | 2 | 5 | 0 | 0 | 0 | 0 |
| Abstain | 17 | 0 | 1 | 0 | 5 | 10 | 1 | 0 | 0 | 0 |
| Amendments | Dossier |
| 297 |
2011/0150(COD) European standardisation
2012/01/16
INTA
15 amendments...
Amendment 23 #
Proposal for a regulation Recital 13 (13) Standards are important tools for undertakings and especially small and medium-sized enterprises (hereinafter ‘SMEs’) which, however, are not adequately involved in the standardisation system so that the risk exists that standards do not take into account the needs and concerns of SME.
Amendment 24 #
Proposal for a regulation Recital 14 (14) European standards are of vital interest for the competitiveness of SMEs which, however, are in
Amendment 25 #
Proposal for a regulation Article 4 – paragraph 2 2. Each European and national standardisation body shall
Amendment 26 #
Proposal for a regulation Article 4 – paragraph 3 – point a (a) the prompt publication of draft standards in such a way that parties established in other Member States have the opportunity to submit comments;
Amendment 27 #
Proposal for a regulation Article 5 – paragraph 1 – introductory part 1. European standardisation bodies shall en
Amendment 28 #
Proposal for a regulation Article 5 – paragraph 2 2. European standardisation bodies shall en
Amendment 29 #
Proposal for a regulation Article 5 a (new) Article 5a Best-practice models European standardisation bodies shall support, foster and disseminate best- practice models for the involvement of stakeholders in national standardisation bodies.
Amendment 30 #
Proposal for a regulation Article 6 – paragraph 2 a (new) 2a. The work programme for the development of European standards referred to in paragraph 1 shall outline how the standardisation work is to be incorporated into the joint EU 2020 strategy and how coherence between the two will be maintained.
Amendment 31 #
Proposal for a regulation Article 6 – paragraph 2 b (new) 2b. The work programme for the development of European standards referred to in paragraph 1 shall outline who is to make what efforts to develop international cooperation and thus internationalise European standardisation work.
Amendment 32 #
Proposal for a regulation Article 6 – paragraph 2 c (new) 2c. The work programme for the development of European standards referred to in paragraph 1 shall be forwarded to the European Parliament and the Council for their opinions.
Amendment 33 #
Proposal for a regulation Article 7 – paragraph 1 1. The Commission may request one or several European standardisation bodies to draft a European standard or European standardisation, deliverable within a set deadline, which is ambitious and to which are annexed clear lists of requirements, interim objectives and details of public funding. They shall be market-driven, take into account the public interest and based on consensus.
Amendment 34 #
Proposal for a regulation Article 7 – paragraph 3 3. The Commission shall inform the relevant European standardisation body, within
Amendment 35 #
Proposal for a regulation Article 13 – paragraph 3 3. The Commission shall decide on the financing arrangements referred to in paragraphs 1 and 2, on the amounts of the grants and, where necessary, on the maximum percentage of financing by type of activity. The Commission shall ensure that the EU funding is only supplementary in nature and is made contingent on compliance with specific requirements, so that funding for European standardisation continues to be provided mainly by the private sector.
Amendment 36 #
Proposal for a regulation Annex 2 – paragraph 3 – point f a (new) (fa) coherence: (i) the technical specifications do not contradict existing national, European and international standards or those in the process of being drafted, nor do they duplicate them. (ii) this provision should respect the principle of technological neutrality and not be applied in an anti-competitive manner.
Amendment 37 #
Proposal for a regulation Annex 2 – point 3 – point f a (new) (fa) coherence: the technical specifications do not contradict existing national, European and international standards or those in the process of being drafted, nor do they duplicate them.
source: PE-478.665
2012/01/25
ITRE
71 amendments...
Amendment 27 #
Proposal for a regulation Recital 2 (2) European standardisation also helps to boost the competitiveness of enterprises by facilitating in particular the free movement of goods and services, network interoperability, means of communication, technological development and innovation. European standardisation strengthens the competitiveness of business when coordinated with the international standardisation system. Standards produce significant positive economic effects, for example by promoting economic interpenetration on the internal market and encouraging the development of new and improved products or markets and improved supply conditions. Standards thus normally increase competition and lower output and sales costs, benefiting economies as a whole. Standards may maintain and enhance quality, provide information and ensure interoperability and compatibility, thereby increasing value for consumers.
Amendment 28 #
Proposal for a regulation Recital 4 (4) European standards play a very important role within the internal market,
Amendment 29 #
Proposal for a regulation Recital 8 (8) The development of voluntary standards on services should be market- driven whereby the needs of the economic operators and stakeholders directly or indirectly affected by the standard prevail and should take into account the public interest and be based on consensus. They should primarily focus on services linked to products and processes. Within the scope of Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications1, standardisation is only permitted on a subsidiarity basis. _________ 1 OJ L 255, 30.9.2005, p. 22.
Amendment 30 #
Proposal for a regulation Recital 8 (8)
Amendment 31 #
Proposal for a regulation Recital 12 (12)
Amendment 32 #
Proposal for a regulation Recital 13 (13) Standards are important tools for undertakings and especially small and medium-sized enterprises (hereinafter
Amendment 33 #
Proposal for a regulation Recital 13 (13) Standards are important tools for undertakings and especially small and medium-sized enterprises (hereinafter 'SME') which, however, are not adequately involved in the standardisation system so that the risk exists that standards do not take into account the needs and concerns of SME. Consequently, it is essential to improve their representation and participation in the standardisation process, particularly in the technical committees. Standardisation rules should encourage SMEs to contribute actively, with innovative technological solutions, to the standardisation process.
Amendment 34 #
Proposal for a regulation Recital 13 (13) Standards are important tools for undertakings and especially small and medium-sized enterprises (hereinafter ‘SME’) which, however, are sometimes under-represented and not adequately involved in the standardisation system so that the risk exists that standards do not sufficiently take into account the needs and concerns of SME. Consequently, it is essential to improve their representation and participation in all phases of the standardisation process, particularly in the technical committees.
Amendment 35 #
Proposal for a regulation Recital 13 (13) Standards are important tools for undertakings and especially small and medium-sized enterprises (hereinafter ‘SME’) which, however, are not adequately involved in the standardisation system so that the risk exists that standards do not take into account the needs and concerns of SME or their potential for contributing innovative technology. Consequently, it is essential to improve their representation and participation in the standardisation process, particularly in the technical committees.
Amendment 36 #
Proposal for a regulation Recital 14 (14) European standards are of vital interest for the competitiveness of SMEs which, however, are in general under- represented in standardisation activities, in particular at European level. Thus, this Regulation should ensure an appropriate representation of SME in the European standardisation process by an entity with appropriate qualifications. Granting SMEs effective membership of the European Standardisation Organisations, including voting rights is expected to have a positive impact on the involvement and participation of SMEs in standardisation.
Amendment 37 #
Proposal for a regulation Recital 15 (15) Standards can have a broad impact on society, in particular on the safety and well-being of citizens, the efficiency of networks, the environment, accessibility and other public policy fields. Therefore, it is necessary to ensure that the role and the input of societal stakeholders in the elaboration of standards is strengthened, through the support of organisations representing the interests of consumers, the environment and societal stakeholders. Granting those organisations effective membership in the European Standardisation Organisations, including voting rights, will have a positive impact on the quality of standards.
Amendment 38 #
Proposal for a regulation Recital 16 (16) Standards should
Amendment 39 #
Proposal for a regulation Recital 17 (17) The viability of the cooperation between the Commission and the European standardisation system depends on careful planning of future requests for the development of standards. This planning could be improved, in particular through the input of interested parties, by introducing mechanisms for collecting opinions and facilitating the exchange of information among all interested parties. Since Directive 98/34/EC already provides for the possibility to request the European standardisation bodies to elaborate European standards, it is appropriate to put in place a better and more transparent planning in an annual work programme which should contain an overview of all requests for standards which the Commission intends to submit to European standardisation bodies.
Amendment 40 #
Proposal for a regulation Recital 26 (26) In view of the very broad field of involvement of European standardisation in support of Union policies and legislation and the different types of standardisation activity, it is necessary to provide for different financing arrangements. This mainly concerns grants without calls for proposals to the European and national standardisation bodies in accordance with the second subparagraph of Article 110(1) of Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities and Article 168(1)(d) of Commission Regulation (EC, Euratom) No 2342/2002 of 23 December 2002 laying down detailed rules for the implementation of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities. Furthermore, the same provisions should apply to those bodies which, whilst not recognised as European standardisation bodies in this Regulation, have been mandated in a basic act and have been entrusted with carrying out preliminary work in support of European standardisation in cooperation with the European standardisation bodies. . In the ITC field, the activities entrusted to such bodies could include, similarly, development of the standards required for implementing EU policies.
Amendment 41 #
Proposal for a regulation Recital 29 (29) The financing of standardisation activities should also be capable of covering preliminary or ancillary activities in connection with the establishment of standards or other standardisation products. This is necessary primarily for work involving research, the preparation of preliminary documents for legislation, inter-laboratory tests and the validation or evaluation of standards. The promotion of standardisation at European and international level should also continue through programmes relating to the technical assistance to, and cooperation with, third countries. With a view to improving market access and boosting the competitiveness of enterprises in the Union, it should be possible to give grants to
Amendment 42 #
Proposal for a regulation Recital 36 (36) The advisory procedure should be used for the implementing decisions with respect to the annual European standardisation work programme and for the implementing decisions concerning the objections to harmonised standards which the Commission considers justified and where the references to the harmonised standard concerned were not yet published in the Official Journal of the European Union, given that the relevant standard did not yet lead to the presumption of conformity with the essential requirements set out in the applicable Union harmonisation legislation.
Amendment 43 #
Proposal for a regulation Recital 37 (37) The examination procedure should be used, in the event of standardisation requests being forwarded to European standardisation bodies and of recognition of technical specifications in the field of information and communication technology, for the implementing decisions with respect to the objections to harmonised standards which the Commission considers justified and where the references to the harmonised standard concerned were already published in the Official Journal of the European Union, given that such decisions could have consequences on the presumption of conformity with the applicable essential requirements.
Amendment 44 #
Proposal for a regulation Article 1 This Regulation establishes rules with regard to the cooperation between European standardisation bodies, national standardisation bodies and the Commission, the establishment of European standards and European standardisation deliverables for products and for services in support of Union legislation and policies, the recognition of technical specifications in the field of information and communication technologies (hereinafter “ICT”)
Amendment 45 #
Proposal for a regulation Article 2 – point 1 – introductory part (1) ‘standard’ means a technical specification, approved by a recognised standard-setting body, for repeated or continuous application, with which compliance is not compulsory, and which is one of the following:
Amendment 46 #
Proposal for a regulation Article 2 – point 1 – point c (c) ‘harmonised standard’ means a European standard adopted on the basis of a request made by the Commission for the application of Union
Amendment 47 #
Proposal for a regulation Article 2 – point 4 (4) ‘technical specification’ means a
Amendment 48 #
Proposal for a regulation Article 3 – paragraph 2 a (new) 2a. The work programme shall be forwarded, before publication, to the organisations referred to in Annex III for an opinion. No later than at the time of publication of its work programme, each national or European standardisation body shall notify the existence thereof to the organisations referred to in Annex III.
Amendment 49 #
Proposal for a regulation Article 3 – paragraph 5 Amendment 50 #
Proposal for a regulation Article 3 – paragraph 5 Amendment 51 #
Proposal for a regulation Article 4 – paragraph 3 – point a (a) the publication of draft standards in such a way that parties established in other Member States have the opportunity to submit comments. If translation is needed, it should be carried out at the expense of the interested party;
Amendment 52 #
Proposal for a regulation Article 5 – title Stakeholder
Amendment 53 #
Proposal for a regulation Article 5 – paragraph 1 – introductory part 1. European standardisation bodies shall en
Amendment 54 #
Proposal for a regulation Article 5 – paragraph 1 – introductory part 1. European standardisation bodies shall en
Amendment 55 #
Proposal for a regulation Article 5 – paragraph 1 – point d a (new) (da) the building of consensus, to be ensured particularly through the recording of the views of the organisations referred to in Annex III;
Amendment 56 #
Proposal for a regulation Article 5 – paragraph 1 – point d b (new) (db) the voting phase, whereby organisations referred to in Annex III are granted voting rights;
Amendment 57 #
Proposal for a regulation Article 5 – paragraph 1 a (new) 1a. Standards should be conceived and adapted so as to take account of SMEs’ characteristics and the SME environment, especially in the case of small craft businesses and microbusinesses, thus enabling them to have improved and less expensive access to standards
Amendment 58 #
Proposal for a regulation Article 5 – paragraph 1 a (new) 1a. The European Standardisation Organisations shall grant effective membership to the organisations referred to in Annex III. Effective membership shall include granting of voting rights.
Amendment 59 #
Proposal for a regulation Article 5 – paragraph 1 b (new) 1b. In order to ensure user access to the European standards established in support of EU legislation and policies, it is necessary to envisage differential systems for establishing prices and the introduction of special fees and discounted standards packages, especially for SMEs, microbusinesses and craft businesses.
Amendment 60 #
Proposal for a regulation Article 5 – paragraph 1 b (new) 1b. In order to ensure the appropriate representation of stakeholders, the transparency of affiliation of members shall be strictly monitored by standardisation bodies.
Amendment 61 #
Proposal for a regulation Article 5 – paragraph 2 2. European standardisation bodies shall en
Amendment 62 #
Proposal for a regulation Article 6 – paragraph 1 1.
Amendment 63 #
Proposal for a regulation Article 6 – paragraph 2 a (new) 2a. The draft European standardisation work programme referred to in this Article shall be published for consultation of the organisations referred to in Annex III.
Amendment 64 #
Proposal for a regulation Article 7 – paragraph 1 1. The Commission may request one or several European standardisation bodies to draft a European standard or European standardisation deliverable within a set deadline. They shall be market-driven, take into account the public interest and based on consensus.
Amendment 65 #
Proposal for a regulation Article 7 – paragraph 1 1. The Commission may request one or several European standardisation bodies to draft a European standard or European standardisation deliverable within a set deadline. They shall be market-driven, take into account the public interest and based on consensus. Requests for drafting standards shall be based on consultations with all the main interested parties.
Amendment 66 #
Proposal for a regulation Article 7 – paragraph 1 a (new) Amendment 67 #
Proposal for a regulation Article 7 – paragraph 2 2. The relevant European standardisation body shall indicate, within
Amendment 68 #
Proposal for a regulation Article 7 – paragraph 3 3. The Commission shall inform the relevant European standardisation body, within
Amendment 69 #
Proposal for a regulation Article 7 – paragraph 3 3. The Commission shall inform the relevant European standardisation body, within
Amendment 70 #
Proposal for a regulation Article 8 – paragraph 4 4. Th
Amendment 71 #
Proposal for a regulation Article 8 – paragraph 5 5. The decision referred to in paragraph 2(b) of this Article shall be adopted in accordance with the examination procedure referred to in Article 18(3), after consultation with the monitoring committee for the corresponding directive for the sector.
Amendment 72 #
Proposal for a regulation Article 9 Either on proposal from a public authority referred to in Directive 2004/18/EC or on its own initiative the Commission may decide
Amendment 73 #
Proposal for a regulation Article 9 Either on proposal from a public authority referred to in Directive 2004/18/EC or on its own initiative the Commission may decide to recognise technical specifications in the field of ICT which are not national, European or international standards and meet the requirements set out in Annex II, as ICT standards for use in policies and public procurement in order to promote interoperability in the field of ICT.
Amendment 74 #
Proposal for a regulation Article 9 – paragraph 1 a (new) 1a. When evaluating conformity of technical specifications with the requirements laid down in Annex II, the Commission shall take due account of a wide range of opinions, including those of the national and European standardisation bodies.
Amendment 75 #
Proposal for a regulation Article 10 Recognised ICT standards referred to in Article 9 shall constitute common technical specifications referred to in Directives 2004/17/CE and 2004/18/CE, and Regulation (EC) No 2342/2002.
Amendment 76 #
Proposal for a regulation Article 10 Recognised ICT standards referred to in Article 9 shall constitute common technical specifications referred to in Directives 2004/17/CE and 2004/18/CE, and Regulation (EC) No 2342/2002.
Amendment 77 #
Proposal for a regulation Article 11 – paragraph 1 – point e (e) the translation, where required by a Member State, of European standards or European standardisation deliverables used in support of Union policies and legislation into the official Union languages other than the working languages of the European standardisation bodies or, in duly justified cases into languages other than the official Union languages,
Amendment 78 #
Proposal for a regulation Article 11 – paragraph 1 – point e (e) the translation
Amendment 79 #
Proposal for a regulation Article 11 – paragraph 1 – point f (f) the drawing up of information to explain, interpret and simplify European standards or European standardisation deliverables, including the drawing up of user guides, summaries of standards, best practice information
Amendment 80 #
Proposal for a regulation Article 13 – paragraph 4 – point b (b) SME, consumer organisations and environmental and social stakeholders are appropriately represented in European standardisation work, as referred to in Article 5(1), provided that relevant experts from those stakeholders are available and willing to participate.
Amendment 81 #
Proposal for a regulation Article 13 – paragraph 4 – point b (b) SME, consumer organisations and environmental and social stakeholders are appropriately represented in European standardisation work and have effective membership of European Standardisation Organisations, as referred to in Article 5(1).
Amendment 82 #
Proposal for a regulation Article 13 – paragraph 4 a (new) 4a. In order to allow SMEs to benefit fully from the understanding and application of the European harmonised standards, the financing granted to the European Standardisation Bodies for the purposes of translation shall cover a significant portion of the total cost incurred and the translation funding procedures shall be simplified. Grants awarded for the translation activities referred to in point (e) of Article 11(1) shall take the form of lump sums per translated page to be paid in advance and upon evidence being provided that European standards are effectively translated.
Amendment 83 #
Proposal for a regulation Article 16 – introductory part The Commission shall be empowered to adopt, after consulting the organisations referred to in Annex III, delegated acts in accordance with Article 17 concerning amendments to the Annexes, in order to:
Amendment 84 #
Proposal for a regulation Article 16 – point a Amendment 85 #
Proposal for a regulation Article 17 – paragraph 2 2. The delegation of power referred to in Article 16 shall be conferred on the Commission for
Amendment 86 #
Proposal for a regulation Article 17 – paragraph 3 3. The delegation of powers referred to in Article 16 may be revoked at any time by the European Parliament or by the Council. The institution which initiated the internal decision-making procedure with regard to revoking the delegation of powers shall make every effort to inform the Commission, within a reasonable time-frame prior to adoption of a final decision, indicating the delegated powers liable to be revoked and the potential grounds for revocation. A decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect the day following the publication of the Decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of the delegated acts already in force.
Amendment 87 #
Proposal for a regulation Article 18 – paragraph 1 1. The Commission shall be assisted by a committee. That
Amendment 88 #
Proposal for a regulation Article 18 – paragraph 4 a (new) 4a. Organisations referred to in Annexes I and III shall be invited to participate as observers at meetings of the Committee.
Amendment 89 #
Proposal for a regulation Article 19 – paragraph 1 – introductory part 1. The European Standardisation Bodies shall send a
Amendment 90 #
Proposal for a regulation Article 19 – paragraph 3 3. By 31 December 2015 and every
Amendment 91 #
Proposal for a regulation Article 20 – paragraph 2 – point b (b)
Amendment 92 #
Proposal for a regulation Annex II – point 2 – point c – point ii (ii) information on (new) standardisation activities was publicly and widely announced through suitable and accessible means.
Amendment 93 #
Proposal for a regulation Annex II – point 2 – point c a (new) (ca) appropriate representation: (i) the technical specifications were developed with the participation of all interested parties; (ii) representation of all categories of stakeholders was balanced.
Amendment 94 #
Proposal for a regulation Annex II – point 3 – point b (b) availability: Specifications are publicly available for implementation and use on reasonable terms (including for a reasonable fee or free of charge) including the right of redistribution independently of the format used.
Amendment 95 #
Proposal for a regulation Annex II – point 3 – point c (c) intellectual property rights essential to the implementation of specifications are
Amendment 96 #
Proposal for a regulation Annex III – point a – introductory part (a) A European horizontal organisation solely representing craft businesses and SMEs in European standardisation activities which:
Amendment 97 #
Proposal for a regulation Annex III – point a – introductory part (a) A European horizontal organisation representing crafts and SME in European standardisation activities which:
source: PE-478.724
2012/02/29
IMCO
211 amendments...
Amendment 66 #
Draft legislative resolution Recital 2 (2) European standardisation also helps to boost the competitiveness of enterprises by facilitating in particular the free movement of goods and services, network interoperability, means of communication, technological development and innovation. Standards produce significant positive economic effects, for example by promoting economic interpenetration on the internal market and encouraging the development of new and improved products or markets and improved supply conditions. Standards thus normally increase competition and lower output and sales costs, benefiting economies as a whole and consumers in particular. Standards may maintain and enhance quality, provide information and ensure interoperability and compatibility, thereby increasing safety and value for consumers.
Amendment 67 #
Proposal for a regulation Recital 2 (2) European standardisation can also help
Amendment 68 #
Proposal for a regulation Recital 3 (3) European standards should continue to be adopted by the European
Amendment 69 #
Proposal for a regulation Recital 3 (3) The European standardisation system should continue to be a voluntary and market driven process and be based on the principles for standardisation as set out by the World Trade Organisation in the context of the Technical Barriers to Trade Agreement. European standards should continue to be adopted by the European standardisation bodies, namely European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (CENELEC) and the European Telecommunications Standards Institute (ETSI).
Amendment 70 #
Proposal for a regulation Recital 4 (4) European standards play a very important role within the internal market,
Amendment 71 #
Proposal for a regulation Recital 4 a (new) (4a) The European Parliament and the Council should be precise when defining the essential requirements in Union legislation harmonising the conditions for the marketing of products in order to avoid misinterpretation on the part of the standardisers with regard to the objectives, and the level of protection, set by the legislation.
Amendment 72 #
Proposal for a regulation Recital 5 a (new) (5a) The European Parliament's Resolution of 21 October 2010 on the future of European standardisation has set out an important number of strategic recommendations regarding the review of the European Standardisation System.
Amendment 73 #
Proposal for a regulation Recital 6 a (new) (6a) When developing harmonised standards, the Commission should always observe the principle of proportionality; standards that seem pointless and incomprehensible to ordinary people should be avoided.
Amendment 74 #
Proposal for a regulation Recital 7 (7) Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market5 establishes general provisions facilitating the exercise of the freedom of establishment for service providers and the free movement of services, while maintaining a high quality of services, with the exception of healthcare and pharmaceutical services provided by health professionals. It obliges the Member States, in cooperation with the Commission, to encourage the development of voluntary European standards with the aim of facilitating compatibility between services supplied by providers in different Member States, information to the recipient and the quality of service provision. However, Directive 98/34/EC only applies to standards for products while standards for services are not expressly covered by it. However, the delineation between services and goods is becoming less relevant in the reality of the internal market. In practice, it is not always possible to clearly distinguish standards on products from standards on services. Many product standards have a service component while standards on services often also partly relate to products. Thus, it is necessary to adapt the legal framework to these new circumstances by extending its scope to standards on services. __________________ 1 OJ L, 27.12.2006
Amendment 75 #
Proposal for a regulation Recital 7 (7) Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market establishes general provisions facilitating the exercise of the freedom of establishment for service providers and the free movement of services, while maintaining a high quality of services, except medical and pharmaceutical services provided by healthcare professionals. It obliges the Member States, in cooperation with the Commission, to encourage the development of voluntary European standards with the aim of facilitating compatibility between services supplied by providers in different Member States, information to the recipient and the quality of service provision. However, Directive 98/34/EC only applies to standards for products while standards for services are not expressly covered by it. However, the delineation between services and goods is becoming less relevant in the reality of the internal market. In practice, it is not always possible to clearly distinguish standards on products from standards on services. Many product standards have a service component while standards on services often also partly relate to products. Thus, it is necessary to adapt the legal framework to these new circumstances by extending its scope to standards on services.
Amendment 76 #
Proposal for a regulation Recital 7 (7) Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market establishes general provisions facilitating the exercise of the freedom of establishment for service providers and the free movement of services, while maintaining a high quality of services. It obliges the Member States, in cooperation with the Commission, to encourage the development of voluntary European standards with the aim of facilitating compatibility between services supplied by providers in different Member States, information to the recipient and the quality of service provision. However, Directive 98/34/EC only applies to standards for products while standards for services are not expressly covered by it. However, the delineation between services and goods is becoming less relevant in the reality of the internal market. In practice, it is not always possible to clearly distinguish standards on products from standards on services. Many product standards have a service component while standards on services often also partly relate to products. Thus, it is necessary to adapt the legal framework to these new circumstances by extending its scope to standards on services, including social services and health services.
Amendment 77 #
Proposal for a regulation Recital 7 a (new) (7a) Due consideration should be taken of already existing Union legislation on services in the internal market, in particular the provisions on labour law in Article 1(6) and (7) of Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market1. __________________ 1 OJ L, 27.12.2006
Amendment 78 #
Proposal for a regulation Recital 7 b (new) Amendment 79 #
Proposal for a regulation Recital 8 (8) The development of voluntary standards on services should be market- driven whereby the needs of the economic operators and stakeholders directly or indirectly affected by the standard prevail and should take into account the public interest and be based on consensus. They should primarily focus on services linked to products and processes. Accordingly, such standards should not cover performance of services provided in the exercise of a liberal profession within the meaning of Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications.
Amendment 80 #
Proposal for a regulation Recital 8 a (new) (8a) This regulation covers standardisation of services related to goods or digital content, such as installation, maintenance, repair or any other processing. However, it does not concern standardisation of intellectual and conceptual services as defined by Directive 2005/36/EC nor does it cover social, healthcare or pharmaceutical services. These services are provided on the basis of relevant professional qualifications in a personal, responsible and professional independent capacity in the interest of the client and the public.
Amendment 81 #
Proposal for a regulation Recital 10 (10) Within the Union, national standards are adopted by national standardisation bodies which could lead to conflicting standards and technical impediments in the internal market. Therefore, it is necessary for the internal market and for the effectiveness of standardisation within the Union to confirm the existing regular exchange of information between the national standardisation bodies, the European standardisation bodies and the Commission, about current and future standardisation work, including the provisions concerning the standstill arrangements applicable to the national standardisation organisations within the framework of the European standardisation organisations. This exchange of information should be aligned with Annex 3 to Agreement on Technical Barriers to Trade approved by Council Decision No 80/271/EEC of 10 December 1979 concerning the conclusion of the Multilateral Agreements resulting from the 1973 to 1979 trade negotiations.
Amendment 82 #
Proposal for a regulation Recital 12 (12)
Amendment 83 #
Proposal for a regulation Recital 12 (12) Standards can contribute to helping European policy address the major
Amendment 84 #
Proposal for a regulation Recital 12 (12) Standards can contribute to helping European policy address the major societal challenges such as climate change, sustainable resource use, ageing, and innovation in general. By driving the development of European or international standards for goods and technologies in these expanding markets, Europe could create a competitive advantage for its companies and facilitate trade, preserve natural resources and promote social inclusion.
Amendment 85 #
Proposal for a regulation Recital 12 (12) Standards can contribute to helping European policy address the major societal challenges such as climate change, sustainable resource use, ageing, the integration of persons with disabilities, social integration and innovation in general. By driving the development of European or international standards for goods and technologies in these expanding markets, Europe could create a competitive advantage for its companies and facilitate trade.
Amendment 86 #
Proposal for a regulation Recital 12 (12) Standards can contribute to helping European policy address the major societal challenges such as climate change, sustainable resource use, ageing, social inclusion, disability and innovation in general. By driving the development of European or international standards for goods and technologies in these expanding markets, Europe could create a competitive advantage for its companies and facilitate trade.
Amendment 87 #
Proposal for a regulation Recital 12 a (new) (12a) Any Union policy and legislative initiative should be in compliance with the United Nations Convention on the Rights of Persons with Disabilities concluded by the European Union on 23 December 2010, and especially Articles 3, 4 and 9.
Amendment 88 #
Proposal for a regulation Recital 12 a (new) (12a) Any Union policy and legislative initiative should be in compliance with the United Nations Convention on the Rights of Persons with Disabilities concluded by the European Union on 23 December 2010, and especially Articles 3, 4 and 9.
Amendment 89 #
Proposal for a regulation Recital 13 (13) Standards are important tools for the competitiveness of undertakings and especially small and medium-sized enterprises (hereinafter ‘SME’)
Amendment 90 #
Proposal for a regulation Recital 13 (13) Standards are important tools for the competitiveness of undertakings and especially small and medium-sized enterprises (hereinafter ‘SME’), wh
Amendment 91 #
Proposal for a regulation Recital 13 (13) Standards are important tools for undertakings and especially small and medium-sized enterprises (hereinafter
Amendment 92 #
Proposal for a regulation Recital 13 (13) Standards are important tools for the competitiveness of undertakings and especially small and medium-sized enterprises (hereinafter 'SME') which, however, are not adequately represented or involved in the standardisation system so that the risk exists that standards do not take into account the needs and concerns of SME. Consequently, it is
Amendment 93 #
Proposal for a regulation Recital 13 a (new) (13a) It is important, to this effect, to encourage the exchange of best practices between National Standardisation Organisations on how to best facilitate and enhance the participation of SMEs in standardisation activities.
Amendment 94 #
Proposal for a regulation Recital 14 (14) European standards are of vital interest for the competitiveness of SMEs which, however, are in
Amendment 95 #
Proposal for a regulation Recital 15 (15) Standards can have a broad impact on society, in particular on the safety and well-being of citizens, the efficiency of networks, the environment, workers' safety and conditions, accessibility and other public policy fields. Therefore, it is necessary to ensure that the role and the input of
Amendment 96 #
Proposal for a regulation Recital 15 (15) Standards can have a broad impact on society, in particular on the safety and well-being of citizens, the efficiency of networks, the environment, accessibility and other public policy fields. Therefore, it is necessary to ensure that the role and the input of
Amendment 97 #
Proposal for a regulation Recital 15 (15) Standards can have a broad impact on society, in particular on the safety and well-being of citizens, the efficiency of networks, the environment, accessibility and other public policy fields. Therefore, it is necessary to ensure that the role and the input of societal stakeholders in the elaboration of standards is strengthened, through the support of organisations representing the interests of consumers, the environment, the business and societal stakeholders.
Amendment 98 #
Proposal for a regulation Recital 15 (15) Standards can have a broad impact on society, in particular on the safety and well-being of citizens, the efficiency of networks, the environment, accessibility and other public policy fields. Therefore, it is necessary to ensure that the role and the input of societal stakeholders in the elaboration of standards is strengthened, through the support of organisations representing the interests of consumers, the environment, business and societal stakeholders.
Amendment 99 #
Proposal for a regulation Recital 15 (15) Standards can have a broad impact on society, in particular on the safety and well-being of citizens, the efficiency of networks, the environment, accessibility and other public policy fields. Therefore, it is necessary to ensure that the role and the input of s
Amendment 100 #
Proposal for a regulation Recital 15 (15) Standards can have a broad impact on society, in particular on the safety and well-being of citizens, the efficiency of networks, the environment, accessibility and other public policy fields. Therefore, it is necessary to ensure that the role and the input of societal stakeholders in the elaboration of standards is strengthened, through the support of organisations representing the interests of consumers, the environment, public health and societal stakeholders.
Amendment 101 #
Proposal for a regulation Recital 15 a (new) (15a) As these stakeholders usually are weak in, or even absent from, national standardisation activities, their effective participation at European level will underpin the relevance of a European standardisation process based on the principle of national delegation, in particular in the standards development process of CEN and CENELEC.
Amendment 102 #
Proposal for a regulation Recital 15 b (new) (15b) In most Member States, public authorities show limited interest in participating in the standards development process, notwithstanding the importance of standardisation as a tool to support EU policies and legislation. Therefore, this Regulation should encourage the participation of public authorities in all national technical committees mirroring the development or revision of European standards requested by the Commission. The participation of national authorities is particularly beneficial to the proper functioning of legislation in the areas covered by the 'New Approach', and for the avoidance of ex-post objections to harmonised standards.
Amendment 103 #
Proposal for a regulation Recital 15 b (new) (15b) In most Member States, public authorities show a limited interest in participating in the standards development process, notwithstanding the importance of standardisation as a tool to support Union policies and legislation. This Regulation should therefore encourage the involvement of such authorities in all the national technical committees that deal with European standards being developed or revised at the request of the Commission. The participation of national authorities is particularly crucial for the proper functioning of legislation in the areas covered by the ‘New Approach’, and for the avoidance of ex-post objections to harmonised standards.
Amendment 104 #
Proposal for a regulation Recital 15 c (new) (15c) National Standardisation Organisations should provide free access to the participation in their standardisation activities of micro and small enterprises, consumers, including people with disabilities, environmentalists, workers and other societal stakeholders, with the view to enhancing their representation in the standardisation process, in particular in the technical committees. Although free access may not in itself ensure the effective participation of those stakeholders in national standardisation activities, it is necessary to reduce current unnecessary barriers that may discourage weaker stakeholders from participating in the standardisation process.
Amendment 105 #
Proposal for a regulation Recital 15 d (new) (15d) European Standardisation Organisations shall ensure that their activities, processing of technical work and provision of European standards and European standardisation deliverables are made accessible to persons with disabilities in all terms.
Amendment 106 #
Proposal for a regulation Recital 16 (16) Standards should
Amendment 107 #
Proposal for a regulation Recital 18 (18) Several Directives harmonizing the conditions for the marketing of products specify that the Commission may request the adoption, by the European standardisation bodies, of harmonised European standards on the basis of which conformity with the applicable essential requirements is presumed. However, many of these legislative acts contain a wide variety of provisions on objections to these standards when the latter do not, or not entirely, cover all applicable requirements. Diverging provisions which lead to uncertainty for economic operators and European standardisation bodies are in particular contained in Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment, Council Directive 93/15/EEC of 5 April 1993 on the harmonisation of the provisions relating to the placing on the market and supervision of explosives for civil uses, Directive 94/9/EC of the European Parliament and the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres, Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft, Directive 95/16/EC of the European Parliament and of the Council of 29 June 1995 on the approximation of the laws of the Member States relating to lifts, Directive 97/23/EC of the European Parliament and of the Council of 29 May 1997 on the approximation of the laws of the Member States concerning pressure equipment, Directive 2004/22/EC of the European Parliament and of the Council of 31 March 2004 on measuring instruments, Directive 2007/23/EC of the European Parliament and of the Council of 23 May 2007 on the placing on the market of pyrotechnic articles, Directive 2009/105/EC of the European Parliament and of the Council of 16 September 2009 relating to simple pressure vessels and Directive 2009/23/EC of the European Parliament and of the Council of 23 April 2009 on non-automatic weighing instruments. Therefore, it is necessary to include in this Regulation the uniform procedure provided for in Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products and repealing Council Decision 93/465/EEC, and delete the relevant provisions in those Directives
Amendment 108 #
Proposal for a regulation Recital 28 (28) Decision No 1639/2006/EC of the European Parliament and of the Council of 24 October 2006 establishing a Competitiveness and Innovation Framework Programme (2007 to 2013), Decision No 1926/2006/EC of the European Parliament and of the Council of 18 December 2006 establishing a programme of Community action in the field of consumer policy (2007-2013) and Regulation (EC) No 614/2007 of the European Parliament and of the Council of 23 May 2007 concerning the Financial Instrument for the Environment (LIFE+) already provide for the possibility of financial support of European organisations representing SME, consumers and environmental interests in standardisation, while specific grants are paid to European organisations representing social interests in standardisation. The financing under Decision No 1639/2006/EC, Decision No 1926/2006/EC and Regulation (EC) No 614/2007 will end on 31 December 2013. It is essential for the development of European standardisation to continue fostering and encouraging the active participation of European organisations representing SME, workers, consumers and environmental and social interests. Such organisations pursue an aim of general European interest and constitute, by virtue of the specific mandate that national non-
Amendment 109 #
Proposal for a regulation Recital 36 (36) The advisory procedure should be used for the implementing decisions with respect to the annual European standardisation work and the objections to harmonised standards which the Commission considers justified and where the references to the harmonised standard concerned were not yet published in the Official Journal of the European Union, given that the relevant standard did not yet lead to the presumption of conformity with the essential requirements set out in the applicable Union harmonisation legislation.
Amendment 110 #
Proposal for a regulation Recital 37 (37) The examination procedure should be used for the implementing decisions with respect to the objections to harmonised standards which the Commission considers justified and where the references to the harmonised standard concerned were already published in the Official Journal of the European Union, given that such decision could have consequences on the presumption of conformity with the applicable essential requirements. National authorities should give their input through their national standardisation organisations during the standardisation process, in order to reduce as much as possible, modifications on the status of standards after the publication in the Official Journal of the European Union.
Amendment 111 #
Proposal for a regulation Article 1 – paragraph 1 This Regulation establishes rules with regard to the cooperation between European standardisation bodies, national standardisation bodies and the Commission, the establishment of those European standards and European standardisation deliverables for products and for services
Amendment 112 #
Proposal for a regulation Article 1 – paragraph 1 This Regulation establishes rules with regard to the cooperation between European standardisation bodies, national standardisation bodies and the Commission, the establishment of European standards and European standardisation deliverables for products and for product-related services in support of Union legislation and policies, the recognition of technical specifications in the field of information and communication technologies (hereinafter “ICT”) and financing of European standardisation.
Amendment 113 #
Proposal for a regulation Article 1 – paragraph 1 a (new) Amendment 114 #
Proposal for a regulation Article 1 – paragraph 1 b (new) This regulation shall not apply to any healthcare services which are provided by health professionals to patients in the exercise of their profession, in particular to assess, maintain or restore patients' state of health, where those activities are reserved to a regulated health profession in the Member State in which the services are provided, whether or not they are provided via healthcare facilities, and regardless of the ways in which they are organised and financed at national level or whether they are public or private.
Amendment 115 #
Proposal for a regulation Article 1 – paragraph 1 b (new) This Regulation shall not apply to any services within health management, which are provided to patients by those being employed in the medical sector when pursuing their profession, notably to recondition, preserve or access a patient's medical condition, where those exercises are being carried out by professionals of a regulated health sector in the Member State in which the services are given, with no regard to the medical equipment and without taking national organisational or financial means nor their being a public or private matter into consideration.
Amendment 116 #
Proposal for a regulation Article 1 – paragraph 1 c (new) Non-material and/or creative services provided by the liberal professions shall be excluded from the scope of the Regulation. Generally speaking, the business of the liberal professions is the personal, autonomous and substantively independent provision – on the basis of specific professional qualifications or conceptual ability – of services of a higher order, in the interests of clients and the general interest. Standardisation in respect of process quality, however, remains permissible.
Amendment 117 #
Proposal for a regulation Article 1 – paragraph 1 d (new) In the field of application of Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications1, standardisation shall be permissible only on a subsidiary basis. _______________ 1 OJ L 255, 30.9.2005, p. 22.
Amendment 118 #
Proposal for a regulation Article 2 – paragraph 1 – point 1 – introductory part (1) ‘standard’ means a technical specification for repeated or continuous application, the draft of which has been subject to public enquiry, with which compliance is not compulsory, and which is one of the following:
Amendment 119 #
Proposal for a regulation Article 2 – paragraph 1 – point 1 – introductory part (1) ‘standard’ means a technical specification established by consensus and approved by a recognised standardisation organisation for repeated or continuous
Amendment 120 #
Proposal for a regulation Article 2 – paragraph 1 – point 1 – introductory part (1) ‘standard’ means a technical specification established by consensus and approved by a recognised organisation for repeated or continuous
Amendment 121 #
Proposal for a regulation Article 2 – paragraph 1 – point 1 – introductory part (1) ‘standard’ means a technical specification established and approved by a recognised organisation, and in line with the principles set out by WTO in the context of the Technical Barriers to Trade Agreement, for repeated or continuous application, with which compliance is not compulsory, and which is one of the following:
Amendment 122 #
Proposal for a regulation Article 2 – paragraph 1 – point 1 – introductory part (1) ‘standard’ means a technical specification for repeated or continuous application, with which compliance is not compulsory, unless referred to in European regulations, and which is one of the following:
Amendment 123 #
Proposal for a regulation Article 2 – paragraph 1 – point 1 – point a (a) ‘international standard’ means a standard adopted by an international standardisation
Amendment 124 #
Proposal for a regulation Article 2 – paragraph 1 – point 1 – point a (a) ‘international standard’ means a standard adopted by an international standardisation body, and made publicly available;
Amendment 125 #
Proposal for a regulation Article 2 – paragraph 1 – point 1 – point b (b) ‘European standard’ means a standard adopted by one of the European standardisation bodies, which is automatically transposed as a national standard in Member States by withdrawal of conflicting national standards during the drafting of which a standstill on national level applies;
Amendment 126 #
Proposal for a regulation Article 2 – paragraph 1 – point 1 – point b (b)
Amendment 127 #
Proposal for a regulation Article 2 – paragraph 1 – point 1 – point b (b) ‘European standard’ means a standard adopted by one of the European standardisation bodies that shall be implemented through its publication as an identical national standard and which obliges Members of European standardisation bodies to withdraw any existing and conflicting national standards;
Amendment 128 #
Proposal for a regulation Article 2 – paragraph 1 – point 1 – point c (c) ‘harmonised standard’ means a European standard adopted on the basis of a request made by the Commission for the application of Union harmonisation legislation. It shall be drafted according to ESO rules, which implies that an ESO consultant testifies that the essential requirements in the corresponding directive have been met, and in addition, in the case of the railway sector, the provisions in the ad hoc Technical Specifications for Interoperability (TSIs);
Amendment 129 #
Proposal for a regulation Article 2 – paragraph 1 – point 1 – point d (d) ‘national standard’ means a standard adopted by a national standardisation body, and made publicly available;
Amendment 130 #
Proposal for a regulation Article 2 – paragraph 1 – point 1 – point d (d) ‘national standard’ means a standard adopted by a national standardisation body, and made publicly available;
Amendment 131 #
Proposal for a regulation Article 2 – paragraph 1 – point 2 (2) ‘European standardisation deliverable’ means any other technical specification than a European standard, adopted by a European standardisation
Amendment 132 #
Proposal for a regulation Article 2 – paragraph 1 – point 4 – point a (a) the characteristics required of a product including levels of quality, performance, interoperability, environmental protection, health, safety or dimensions, including the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures;
Amendment 133 #
Proposal for a regulation Article 2 – paragraph 1 – point 4 – point a (a) the characteristics required of a product including levels of quality, performance, interoperability, environmental protection, health, safety or dimensions, including the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures;
Amendment 134 #
Proposal for a regulation Article 2 – paragraph 1 – point 4 – point c (c) the characteristics required of a service including levels of quality, performance, interoperability, protection of the environment and public health, safety, including the requirements applicable to the provider as regards the information to be made available to the recipient, as referred to in Article 22(1) to (3) of Directive 2006/123/EC;
Amendment 135 #
Proposal for a regulation Article 2 – paragraph 1 – point 6 (6) ‘service’ means any self-employed economic activity related to goods or digital content, such as installation, maintenance, repair or any other processing, normally provided for remuneration, as referred to in Article 57 of the Treaty;
Amendment 136 #
Proposal for a regulation Article 2 – paragraph 1 – point 6 6. ‘product-related service’ means any se
Amendment 137 #
Proposal for a regulation Article 2 – paragraph 1 – point 6 (6) ‘service’ means any self-employed economic activity normally provided for remuneration, as referred to in Article 57 of the Treaty
Amendment 138 #
Proposal for a regulation Article 2 – paragraph 1 – point 8 (8) ‘International standardisation body’ means the International Organisation for Standardization (ISO), the International Electrotechnical Commission (IEC)
Amendment 139 #
Proposal for a regulation Article 2 – paragraph 1 – point 8 a (new) (8a) ‘Consensus’ means a general agreement, characterised by the absence of sustained opposition to substantial issues by any important part of the concerned interests / stakeholders and by a process that involves seeking to take into account the views of all parties concerned and to reconcile any conflicting arguments.
Amendment 140 #
Proposal for a regulation Article 3 – paragraph 1 1. At least once a year, each European and national standardisation body shall establish its work programme. That work programme shall contain information on the standards and European standardisation deliverables which it intends to prepare or amend, which it is preparing or amending and which it has adopted in the preceding period, unless these are identical or equivalent transpositions of international or European standards. On publication of a new European standard, all conflicting national standards shall be withdrawn.
Amendment 141 #
Proposal for a regulation Article 3 – paragraph 4 4. No later than
Amendment 142 #
Proposal for a regulation Article 4 – paragraph 1 1. Each European and national standardisation body shall send, at least in electronic form, any draft national standard, European standard and European standardisation deliverable to other European and national standardisation bodies and the Commission, upon their request.
Amendment 143 #
Proposal for a regulation Article 4 – paragraph 1 1. Each European and national standardisation body shall systematically send any draft national standard, European standard and European standardisation deliverable to other European and national standardisation bodies and the Commission
Amendment 144 #
Proposal for a regulation Article 4 – paragraph 1 1. Each European and national standardisation body shall systematically send any draft national standard, European standard and European standardisation deliverable to other European and national standardisation bodies and the Commission
Amendment 145 #
Proposal for a regulation Article 4 – paragraph 2 2. Each European and national standardisation body shall
Amendment 146 #
Proposal for a regulation Article 4 – paragraph 2 2. Each European and national standardisation body shall promptly reply to, and take due account of, any comments received from any other European and national standardisation body and the Commission with respect to any such draft. The reply by a national standardisation body shall be provided within a maximum period of three months.
Amendment 147 #
Proposal for a regulation Article 4 – paragraph 3 – point a (a) ensure access to the publication of draft national standards in such a way that
Amendment 148 #
Proposal for a regulation Article 4 – paragraph 3 – point b a (new) (ba) the avoidance of any act of recognition, approval or use by reference to a national standard adopted in breach of Articles 3 or 4 of this Regulation.
Amendment 149 #
Proposal for a regulation Article 4 – paragraph 3 a (new) 3a. During the preparation of a European standard or after its approval, National Standardisation Organisations shall not take any action which could prejudice the harmonisation intended and, in particular, shall not publish in the field in question a new or revised national standard which is not completely in line with any existing European standard. On publication of a new European standard, all conflicting national standards shall be withdrawn.
Amendment 150 #
Proposal for a regulation Article 4 – paragraph 3 a (new) 3a. During the preparation of a European standard or after its approval, National Standardisation Organisations shall not take any action which could prejudice the harmonisation intended and, in particular, shall not publish in the field in question a new or revised national standard which is not completely in line with any existing European standard. On publication of a new European standard, all conflicting standards shall be withdrawn.
Amendment 151 #
Proposal for a regulation Article 5 – paragraph 1 – introductory part 1. National and European
Amendment 152 #
Proposal for a regulation Article 5 – paragraph 1 – introductory part 1. European standardisation bodies shall ensure
Amendment 153 #
Proposal for a regulation Article 5 – paragraph 1 – introductory part 1. National and European standardisation bodies shall ensure an appropriate representation of small and medium-sized enterprises (hereinafter 'SME'), consumer organisations and environmental and social stakeholders, in particular through the organisations referred to in Annex III, at the policy development level and at least at the following stages of the development of European standards or European standardisation deliverables:
Amendment 154 #
Proposal for a regulation Article 5 – paragraph 1 – introductory part 1. European
Amendment 155 #
Proposal for a regulation Article 5 – paragraph 1 – introductory part 1. European standardisation bodies shall ensure an appropriate representation and participation of small and medium-sized enterprises (hereinafter ‘SME’), consumer organisations and environmental and social stakeholders and representatives of employers and employees (hereinafter 'social partners'), in particular through the organisations referred to in Annex III, at the policy development level and at least at the following stages of the development of European standards or European standardisation deliverables:
Amendment 156 #
Proposal for a regulation Article 5 – paragraph 1 – introductory part 1. European standardisation bodies shall
Amendment 157 #
Proposal for a regulation Article 5 – paragraph 1 – introductory part 1. European standardisation bodies shall ensure an appropriate representation and participation of small and medium-sized enterprises (hereinafter 'SME'), consumer organisations and environmental and social stakeholders, in particular through the organisations referred to in Annex III, at the policy development level and at least at the following stages of the development of European standards or European standardisation deliverables:
Amendment 158 #
Proposal for a regulation Article 5 – paragraph 1 – introductory part 1. European standardisation bodies shall ensure
Amendment 159 #
Proposal for a regulation Article 5 – paragraph 1 – introductory part 1. European standardisation bodies shall en
Amendment 160 #
Proposal for a regulation Article 5 – paragraph 1 – point d a (new) (da) the voting phase, whereby organisations referred to in Annex III shall be granted voting rights;
Amendment 161 #
Proposal for a regulation Article 5 – paragraph 1 – point d b (new) (db) the consensus-building, through the recording of the views of the organisations referred to in Annex III, and their consideration in the assessment on whether consensus has been reached;
Amendment 162 #
Proposal for a regulation Article 5 – paragraph 1 – point d a (new) (da) consensus building;
Amendment 163 #
Proposal for a regulation Article 5 – paragraph 1 – point e a (new) (ea) the vote: during a transitional period organisations referred to in Annex III shall be granted voting rights to items to which a representative of such an organisation has contributed at technical level and as long as the respective stakeholder group is not systematically and appropriately represented in at least 2/3 of the National Standardisation Organisations.
Amendment 164 #
Proposal for a regulation Article 5 – paragraph 1 – point e b (new) (eb) In order to ensure the appropriate representation of stakeholders and to improve the consensus building process, the transparency of affiliation of members shall be promoted and monitored by European Standardisation Organisations.
Amendment 165 #
Proposal for a regulation Article 5 – paragraph 1 a (new) 1a. In order to ensure the appropriate representation of stakeholders and to improve the consensus building process, the transparency of affiliation of members shall be strictly enforced and monitored by European Standardisation Organisations.
Amendment 166 #
Proposal for a regulation Article 5 – paragraph 1 b (new) 1b. An independent appeal procedure, managed by an impartial conciliation panel, shall monitor on cases of over- representation of one or more categories of stakeholders, and take due consideration of any sustained opposition at technical committee level.
Amendment 167 #
Proposal for a regulation Article 5 – paragraph 1 c (new) Amendment 168 #
Proposal for a regulation Article 5 – paragraph 1 d (new) 1d. The European Standardisation Organisations shall grant an 'effective membership' to the organisations referred to in Annex III in order to strengthen the representation of those stakeholders who are often weak in, or absent from, the mirror standardisation committees at national level.
Amendment 169 #
Proposal for a regulation Article 5 – paragraph 1 d (new) 1d. The European Standardisation Organisations shall grant an 'effective membership' to those organisations referred to in Annex III of this Regulation in order to strengthen the representation of those stakeholders who are often weak in, or absent from, the mirror standardisation committees at national level.
Amendment 170 #
Proposal for a regulation Article 5 – paragraph 1 d (new) 1d. The European Standardisation Organisations shall grant an 'effective membership' to the organisations referred to in Annex III in order to strengthen the representation of those stakeholders who are often weak in, or absent from, the mirror standardisation committees at national level.
Amendment 171 #
Proposal for a regulation Article 5 – paragraph 2 2. European standardisation bodies shall en
Amendment 172 #
Proposal for a regulation Article 5 – paragraph 2 2. European standardisation bodies shall ensure an appropriate representation, at technical level, of relevant public authorities including those responsible for market surveillance in the Member States, employers and employees as representatives for occupational safety and undertakings, research centres and universities and other legal entities, in standardisation activities concerning an emerging area with significant policy or technical innovation implications
Amendment 173 #
Proposal for a regulation Article 5 – paragraph 2 2. European standardisation bodies shall en
Amendment 174 #
Proposal for a regulation Article 5 a (new) Article 5 a Access of SMEs to standards 1. National Standardisation Organisations shall promote and facilitate the access of SMEs to standards and their development, in particular, through; (a) making available free of charge on their website abstracts of standards; (b) applying special rates for the provision of standards to SMEs and providing bundles of standards at a reduced price; (c) identifying, in their annual work programmes, the standardisation projects which are of particular interest for SMEs; (d) providing special rates to SMEs for participation in standardisation activities; 2. National Standardisation Organisations shall send an annual report to the European Standardisation organisations with regard to their actions to comply with the requirements laid down in paragraph 1 and all other measures to improve the participation of SMEs in their standardisation activities. They shall publish that report on their website.
Amendment 175 #
Proposal for a regulation Article 5 a (new) Article 5 a Access of SMEs to standards 1. National Standardisation Organisations shall promote and facilitate – within the principle of national delegation – the access of SMEs to standards and their development, in particular through: (a) identifying, in their annual work programmes, the standardisation projects which are of particular interest for SMEs; (b) give access to SMEs to standardisation activities without obliging them to become a member; (c) give SMEs the possibility to apply at technical committee level for an exemption from the contribution to cover costs.
Amendment 176 #
Proposal for a regulation Article 5 a (new) Article 5 a Access of SMEs to standards 1. National Standardisation Organisations shall promote and facilitate the access of SMEs to standards and their development, in particular through: (a) making available free of charge on their website abstracts of standards; (b) applying special rates for the provision of standards to SMEs and providing bundles of standards at a reduced price; (c) identifying, in their annual work programmes, the standardisation projects which are of particular interest for SMEs; (d) providing free access to draft standards for SMEs to participate in standardisation activities; (e) give access to SMEs to standardisation activities without obliging them to become a member; (f) give SMEs the possibility to apply at technical committee level for an exemption from the contribution to cover costs. 2. National Standardisation Organisations shall send an annual report to the European Standardisation Organisations with regard to their actions to comply with the requirements laid down in paragraph 1 and all other measures to improve the participation of SMEs in their standardisation activities. They shall publish that report on their website.
Amendment 177 #
Proposal for a regulation Article 5 a (new) Article 5 a Access of SMEs to Standards National Standardisation Organisations shall promote and facilitate the access of SMEs to standards and their development by applying special rates for the provision of standards to SMEs and providing bundles of standards at a reduced price. Member States should also consider exempting microenterprises from payment for these services.
Amendment 178 #
Proposal for a regulation Article 5 a (new) Article 5 a Access of SMEs to standards 1. National Standardisation Organisations shall promote and facilitate the access of SMEs to the development of standards, in particular through: (a) making available free of charge on their website abstracts of standards (b) applying special rates for the provision of standards to SMEs and providing bundles of standards at a reduced price (c) identifying, in their annual work programmes, the standardisation projects which are of particular interest for SMEs; (d) providing low barrier access to SMEs to participate in standardisation activities.
Amendment 179 #
Proposal for a regulation Article 5 a (new) Article 5a Access of SMEs to standards 1. National standardisation organisations shall promote and facilitate the access of SMEs to standards and their development, in particular: (a) by making available free of charge on their website abstracts of standards; (b) through special prices for making standards available to SMEs and price reductions for packages of standards; (c) by identifying, in their annual work programmes, those standardisation projects which are of particular interest for SMEs; (d) through free access for SMEs to participation in the preparation of draft standards. 2. National standardisation organisations shall send an annual report to the European standardisation organisations with regard to their actions to comply with the requirements laid down in paragraph 1 and all other measures to improve the participation of SMEs in their standardisation activities. They shall publish that report on their website.
Amendment 180 #
Proposal for a regulation Article 5 a (new) Article 5 a Access of SMEs to standards 1. National Standardisation Organisations shall promote and facilitate the access of SMEs to standards and their development, in particular through: (a) making available free of charge on their website abstracts of standards; (b) applying special rates for the provision of standards to SMEs and providing bundles of standards at a reduced price; (c) identifying, in their annual work programmes, the standardisation projects which are of particular interest for SMEs; (d) providing free access to SMEs for participating in standardisation activities while not increasing the costs of participating in standardisation for the other stakeholders. 2. National Standardisation Organisations shall send an annual report to the European Standardisation Organisations with regard to their actions to comply with the requirements laid down in paragraph 1 and all other measures to improve the participation of SMEs in their standardisation activities. They shall publish that report on their website.
Amendment 181 #
Proposal for a regulation Article 5 b (new) Article 5 b Access to the standardisation process National Standardisation Organisations shall provide free access to the participation in their standardisation activities of micro and small enterprises, consumers, including people with disabilities, environmentalists, workers and other societal stakeholders.
Amendment 182 #
Proposal for a regulation Article 5 c (new) Article 5 c Participation of public authorities in European Standardisation Member States shall encourage participation of public authorities, in particular market surveillance authorities, in national standardisation activities aimed at the development or revision of standards requested by the Commission in accordance with Article 7(1).
Amendment 183 #
Proposal for a regulation Article 5 c (new) Article 5c Participation of public authorities in European standardisation Member States shall encourage the participation of public authorities, including market surveillance authorities, in national standardisation activities aimed at the development or revision of standards requested by the Commission in accordance with Article 7(1).
Amendment 184 #
Proposal for a regulation Article 6 – paragraph 1 1. The Commission shall adopt an annual European standardisation work programme which shall indicate the European standards and European standardisation deliverables that it intends to request from the European standardisation bodies in accordance with Article 7(1).
Amendment 185 #
Proposal for a regulation Article 6 – paragraph 1 1.
Amendment 186 #
Proposal for a regulation Article 6 – paragraph 2 2. The European standardisation work programme referred to in paragraph 1 shall specify the specific objectives and policies for the European standards and other European standardisation deliverables that the Commission intends to request from the European standardisation bodies. In cases of urgency the Commission can issue requests
Amendment 187 #
Proposal for a regulation Article 6 – paragraph 2 a (new) 2a. This annual European standardisation work programme shall be subject to review with all stakeholders in order to ensure its market relevance.
Amendment 188 #
Proposal for a regulation Article 6 – paragraph 2 a (new) 2a. A European Standardisation System Strategy Forum shall be set up by the Commission in order to consult and coordinate relevant European stakeholders and interested parties, including Annex III organisations, in the perspective of the European policy priorities and initiatives. This multi- stakeholder platform shall be consulted prior to the adoption of the multiannual European standardisation work programme referred to in paragraph 1 and on each standardisation request referred to in Article 7(1). This Forum shall also be used as the multi-stakeholder platform in the field of ICT proposed in the Commission Communication COM(2011)311.
Amendment 189 #
Proposal for a regulation Article 7 – paragraph 1 1. The Commission may request one or several European standardisation bodies to draft a European standard or European standardisation deliverable within a set deadline. They shall be market-driven, take into account the p
Amendment 190 #
Proposal for a regulation Article 7 – paragraph 1 1. The Commission may request one or several European standardisation bodies to draft a European standard or European standardisation deliverable within a
Amendment 191 #
Proposal for a regulation Article 7 – subparagraph 1 a (new) The request referred to in subparagraph 1 shall be adopted after consulting within a reasonable deadline the committee of national experts set up by the corresponding sectorial directive where it exists.
Amendment 192 #
Proposal for a regulation Article 7 – paragraph 1 1. The Commission may request one or several European standardisation bodies to draft a European standard or European standardisation deliverable within a set deadline. They shall be market-driven, comply with the principle of universal design, take into account the public interest and be based on consensus. European standardisation bodies shall observe this deadline without prejudice to the requirement referred to in Article 5(1).
Amendment 193 #
Proposal for a regulation Article 7 – paragraph 1 1. The Commission may request one or several European standardisation bodies to draft a European standard or European standardisation deliverable within a set deadline. They shall be market-driven, take into account the public interest and based on consensus. The European Stakeholders Organisations referred to in Annex III shall be informed accordingly.
Amendment 194 #
Proposal for a regulation Article 7 – paragraph 1 1. The Commission may request one or several European standardisation bodies to draft a European standard or European standardisation deliverable within a set deadline. They shall be market-driven, take into account the public interest, including accessibility for persons with disabilities, and based on consensus.
Amendment 195 #
Proposal for a regulation Article 7 – paragraph 2 2. The relevant European standardisation body shall indicate, within
Amendment 196 #
Proposal for a regulation Article 7 – paragraph 3 3. The Commission shall inform the relevant European standardisation body, within
Amendment 197 #
Proposal for a regulation Article 7 – paragraph 3 3. The Commission shall inform the relevant European standardisation body, within t
Amendment 198 #
Proposal for a regulation Article 8 – paragraph 1 1. When a Member State or the European Parliament considers that a harmonised standard does not entirely satisfy the requirements which it aims to cover and which are set out in the relevant Union legislation, it shall inform the Commission thereof.
Amendment 199 #
Proposal for a regulation Article 8 – paragraph 1 1. When either a Member State or the European Parliament considers that a harmonised standard does not entirely satisfy the requirements which it aims to cover and which are set out in the relevant Union legislation, it shall inform the Commission thereof with a detailed explanation and evidence to sustain its claim. The Commission shall without delay convene the European Standardisation System Strategy Forum referred to in Article 6(2a).
Amendment 200 #
Proposal for a regulation Article 8 – paragraph 1 1. When a Member State considers that a harmonised standard does not entirely satisfy the requirements which it aims to cover and which are set out in the relevant Union legislation, it shall inform the Commission thereof, substantiating its complaint in detail.
Amendment 201 #
Proposal for a regulation Article 8 – paragraph 1 1. When a Member State considers that a harmonised standard does not entirely satisfy the requirements which it aims to cover and which are set out in the relevant Union legislation, it shall inform the Commission thereof, with detailed justification and evidence to sustain its claim.
Amendment 202 #
Proposal for a regulation Article 8 – paragraph 3 a (new) Amendment 203 #
Proposal for a regulation Article 8 – paragraph 4 4. The decision referred to in paragraph 2(a) of this Article shall be adopted in accordance with the advisory procedure referred to in Article 18(2) following the consultation of the European Standardisation System Strategy Forum referred to in Article 6(2a).
Amendment 204 #
Proposal for a regulation Article 8 – paragraph 4 4. The decision referred to in paragraph 2(a) of this Article shall be adopted in accordance with the advisory procedure referred to in Article 18(2), after consulting within a reasonable deadline the committee of national experts set up by the corresponding sectoral directive where it exists.
Amendment 205 #
Proposal for a regulation Article 8 – paragraph 5 5. The decision referred to in paragraph 2(b) of this Article shall be adopted in accordance with the examination procedure referred to in Article 18(3) following the consultation of the European Standardisation System Strategy Forum referred to in Article 6(2a).
Amendment 206 #
Proposal for a regulation Article 8 – paragraph 5 5. The decision referred to in paragraph 2(b) of this Article shall be adopted in accordance with the examination procedure referred to in Article 18(3), after consulting within a reasonable deadline the committee of national experts set up by the corresponding sectoral directive where it exists.
Amendment 207 #
Proposal for a regulation Article 8 – paragraph 5 a (new) 5a. When the Commission has not been informed of any objection to a harmonised standard or has considered that the objection is not justified, it shall publish it without delay in the Official Journal of European Union.
Amendment 208 #
Proposal for a regulation Article 9 – title Recognition and use of technical specifications in the field of ICT
Amendment 209 #
Proposal for a regulation Article 9 – title Recognition and use of technical specifications in the field of ICT
Amendment 210 #
Proposal for a regulation Article 9 – title Recognition and use of technical specifications in the field of ICT
Amendment 211 #
Proposal for a regulation Article 9 – title Recognition and use of technical specifications in the field of ICT
Amendment 212 #
Proposal for a regulation Article 9 – title Re
Amendment 213 #
Proposal for a regulation Article 9 – paragraph 1 Either on proposal from a
Amendment 214 #
Proposal for a regulation Article 9 – paragraph 1 Either on proposal from a public authority referred to in Directive 2004/18/EC or on its own initiative the Commission may decide, after consultation with representatives of all stakeholders, including the European Standardisation Organisations, to recognise technical specifications which are not national, European or international standards and meet the requirements set out in Annex II, as ICT standards.
Amendment 215 #
Proposal for a regulation Article 9 – paragraph 1 Either on proposal from a
Amendment 216 #
Proposal for a regulation Article 9 – paragraph 1 Either on proposal from a public authority referred to in Directive 2004/18/EC or on its own initiative the Commission may decide, after having consulted all parties concerned, to recognise technical specifications which are not national, European or international standards and meet the requirements set out in Annex II, as ICT standards.
Amendment 217 #
Proposal for a regulation Article 9 – paragraph 1 Either on proposal from a public authority referred to in Directive 2004/18/EC or on its own initiative the Commission may decide to re
Amendment 218 #
Proposal for a regulation Article 9 – paragraph 1 Either on proposal from a Member State, a public authority referred to in Directive 2004/18/EC or on its own initiative the Commission may decide
Amendment 219 #
Proposal for a regulation Article 10 – paragraph 1 ICT
Amendment 220 #
Proposal for a regulation Article 10 – paragraph 1 Recognised ICT standards referred to in Article 9 shall constitute common technical specifications referred to in Directives 2004/17/CE and 2004/18/CE, and Regulation (EC) No 2342/2002.
Amendment 221 #
Proposal for a regulation Article 10 a (new) Article 10 a Use of ICT standards for social services including health services This Regulation shall be without prejudice to standards on services. The European Standardisation System shall take into account general provisions facilitating the exercise of social services including health services.
Amendment 222 #
Proposal for a regulation Article 11 – paragraph 1 – point b Amendment 223 #
Proposal for a regulation Article 11 – paragraph 1 – point c (c) the performance of preliminary or ancillary work in connection with European standardisation, including studies, cooperation activities, seminars, evaluations, comparative analyses, research work, laboratory work, inter-laboratory tests, conformity evaluation work and measures to ensure that the periods for the development and the revision of European standards or European standardisation deliverables are shortened without causing detriment to the principles of openness, quality, transparency and consensus among all interested parties;
Amendment 224 #
Proposal for a regulation Article 11 – paragraph 1 – point c (c) the performance of preliminary or ancillary work in connection with European standardisation, including studies, cooperation activities, including international cooperation, seminars, evaluations, comparative analyses, research work, laboratory work, inter-laboratory tests, conformity evaluation work and measures to ensure that the periods for the development and the revision of European standards or European standardisation deliverables are shortened;
Amendment 225 #
Proposal for a regulation Article 11 – paragraph 1 – point c (c) the performance of preliminary or ancillary work in connection with European standardisation, including studies, cooperation activities (including international co-operation), seminars, evaluations, comparative analyses, research work, laboratory work, inter-laboratory tests, conformity evaluation work and measures to
Amendment 226 #
Proposal for a regulation Article 11 – paragraph 1 – point d (d) the activities of the central secretariats of the European standardisation bodies, including policy development, the coordination of standardisation activities, the processing of technical work and the provision of information to interested parties. Those activities shall be made accessible to persons with disabilities to the same level as for anyone else participating;
Amendment 227 #
Proposal for a regulation Article 11 – paragraph 1 – point d (d) the activities of the central secretariats of the European standardisation bodies, including policy development, the coordination of standardisation activities, international regulatory dialogue, the processing of technical work and the provision of information to interested parties;
Amendment 228 #
Proposal for a regulation Article 11 – paragraph 1 – point d (d) the activities of the central secretariats of the European standardisation bodies, including policy development, international and regulatory dialogues, the coordination of standardisation activities, the processing of technical work and the provision of information to interested parties;
Amendment 229 #
Proposal for a regulation Article 11 – paragraph 1 – point d (d) the activities of the central secretariats of the European standardisation bodies, including policy development, international cooperation and dialogues in the field of standards, the coordination of standardisation activities, the processing of technical work and the provision of information to interested parties;
Amendment 230 #
Proposal for a regulation Article 11 – paragraph 1 – point e (e) the translation
Amendment 231 #
Proposal for a regulation Article 11 – paragraph 1 – point f (f) the drawing up of accessible information to explain, interpret and simplify European standards or European standardisation deliverables, including the drawing up of user guides, best practice information and awareness-building actions. Such information and material shall be available for persons with disabilities;
Amendment 232 #
Proposal for a regulation Article 11 – paragraph 1 – point f (f) the drawing up of information to explain, interpret and simplify European standards or European standardisation deliverables, including the drawing up of user guides, best practice information and awareness-building actions. Such information and material shall be available in accessible electronic format and/or accessible format for persons with disabilities;
Amendment 233 #
Proposal for a regulation Article 11 – paragraph 1 – point f (f) the drawing up of information to explain, interpret and simplify European standards or European standardisation deliverables, including the drawing up of user guides, abstracts of standards, best practice information and awareness- building actions;
Amendment 234 #
Proposal for a regulation Article 11 – paragraph 1 – point f (f) the drawing up of information to explain, interpret and
Amendment 235 #
Proposal for a regulation Article 11 – paragraph 1 – point g a (new) (ga) the distribution of harmonised standards free of charge;
Amendment 236 #
Proposal for a regulation Article 12 – paragraph 1 – point b (b) legal and technical expertise, including studies, in relation to assessment of the need for, and the development of, European standards and European standardisation deliverables, and training of experts;
Amendment 237 #
Proposal for a regulation Article 13 – paragraph 2 – point a (a) grants for actions, based on an annual indicative work plan proposed by the European Standardisation Organisations;
Amendment 238 #
Proposal for a regulation Article 13 – paragraph 2 – point b (b) operating grants for the European
Amendment 239 #
Proposal for a regulation Article 13 – paragraph 2 a (new) 2a. The Commission shall ensure that proposals for grants for actions and operating grants are evaluated within two months after their submission by the European Standardisation Organisations, and that where proposals are approved the contracts can be signed within two additional months.
Amendment 240 #
Proposal for a regulation Article 13 – paragraph 3 3. The Commission shall
Amendment 241 #
Proposal for a regulation Article 13 – paragraph 3 3. The Commission, after consulting the European Standardisation Bodies, shall decide on the financing arrangements referred to in paragraphs 1 and 2, on the amounts of the grants and, where necessary, on the maximum percentage of financing by type of activity.
Amendment 242 #
Proposal for a regulation Article 13 – paragraph 3 a (new) 3a. In addition, and notwithstanding the above, for grants for actions, the Commission shall agree on a funding percentage of the annual work plan.
Amendment 243 #
Proposal for a regulation Article 13 – paragraph 4 – point b (b) SME, consumer organisations and environmental and social stakeholders are appropriately represented in European standardisation work, as referred to in Article 5(1) provided that relevant experts from those stakeholders are available and willing to participate.
Amendment 244 #
Proposal for a regulation Article 13 – paragraph 4 – point b (b) SME, consumer organisations and environmental and social stakeholders are appropriately represented and have appropriate participation in European standardisation work, as referred to in Article 5(1).
Amendment 245 #
Proposal for a regulation Article 13 – paragraph 4 – point b (b) European Standardisation Organisations enable the appropriate participation of SMEs, consumer organisations, employees, and environmental and social stakeholders are appropriately represented in European standardisation work, as referred to in Article 5(1).
Amendment 246 #
Proposal for a regulation Article 16 – paragraph 1 – point b (b) adapt the criteria for
Amendment 247 #
Proposal for a regulation Article 16 – paragraph 1 – point c a (new) (ca) The decisions referred to in points (a) and (b) shall be adopted after consultation with the European Standards Organisations and the European Standardisation System Strategy Forum referred to in Article 6(2a).
Amendment 248 #
Proposal for a regulation Article 16 – paragraph 1 a (new) (ca) The decisions referred to in points (a) and (b) shall be adopted after consultation with the European standardisation organisations.
Amendment 249 #
Proposal for a regulation Article 18 – paragraph 1 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. The Committee shall meet at least two times per year with the European and national standardisation organisations.
Amendment 250 #
Proposal for a regulation Article 18 a (new) Article 18 a Multi-stakeholder Platform 1. A Multi-stakeholder Platform shall be set up to advise the Commission and the Committee referred to in Article 18 on matters relating to the implementation of the European standardisation policy in its connection with the regulatory approach to standardisation and its economic and societal impact. 2. The Multi-stakeholder Platform shall be composed of: a. Representatives from Member States' public authorities; b. The European organisations referred to in Annex III; c. The European Standardisation Organisations; d. European organisations representing industry and other societal stakeholders. 3. The Multi-stakeholder Platform shall be consulted: a. During the preparation of requests for new standards to the European Standardisation Organisations in accordance with Article 7(1). b. Whenever shortcomings in standards are identified by any relevant stakeholder including market surveillance authorities.
Amendment 251 #
Proposal for a regulation Article 19 – paragraph 1 – introductory part 1. The European Standardisation Bodies shall send an annual report on the implementation of this Regulation to the Commission. It shall contain
Amendment 252 #
Proposal for a regulation Article 19 a (new) Article 19 a Review This regulation shall be reviewed five years after its entry into force to assess progress against its objectives.
Amendment 253 #
Proposal for a regulation Article 20 – paragraph 2 – point c Amendment 254 #
Proposal for a regulation Article 21 – paragraph 2 Amendment 255 #
Proposal for a regulation Article 21 – paragraph 2 Amendment 256 #
Proposal for a regulation Annex 2 – heading 1 REQUIREMENTS FOR THE
Amendment 257 #
Proposal for a regulation Annex 2 – point 2 – point a – paragraph 1 the technical specifications were developed on the basis of open decision-making accessible to all interested
Amendment 258 #
Proposal for a regulation Annex 2 – point 2 – point c – point iii (iii) participation of all interested categories of interested
Amendment 259 #
Proposal for a regulation Annex 2 – point 2 – point c a (new) (ca) appropriate representation: (i) the technical specifications were developed with the participation of all interested parties; (ii) representation of all categories of interested stakeholders was balanced.
Amendment 260 #
Proposal for a regulation Annex 2 – point 3 – point c (c) intellectual property rights essential to the implementation of specifications are licensed to applicants on a (fair) reasonable and non-discriminatory basis ((F)RAND), which includes
Amendment 261 #
Proposal for a regulation Annex 2 – point 3 – point f a (new) (fa) coherence: the specifications are not in conflict with existing European or international standards.
Amendment 262 #
Proposal for a regulation Annex 2 – point 3 – point f a (new) (fa) the principle of coherence is respected: the technical specifications must not contradict existing national, European and international standards or those in the process of being drafted, nor must they duplicate them.
Amendment 263 #
Proposal for a regulation Annex 2 – point 3 – point f b (new) (fb) legitimation process: the specifications have been approved following a legitimation process, including a public enquiry involving the European and national standardisation bodies.
Amendment 264 #
Proposal for a regulation Annex 3 – point a – introductory part (a) A European horizontal organisation representing crafts and SMEs in European standardisation activities which:
Amendment 265 #
Proposal for a regulation Annex 3 – point a – introductory part (a) A European and national organisation representing SMEs in European standardisation activities which:
Amendment 266 #
Proposal for a regulation Annex 3 – point b – point ii (ii) has as its statutory objectives and activities to represent consumer interests, including consumers who are particularly vulnerable because of their mental or physical disabilities, age or credulity, in the standardisation process at European level;
Amendment 267 #
Proposal for a regulation Annex 3 – point d – introductory part (d) A European organisation representing social interests, understood as a trade union or an organisation representing employees, in European standardisation activities which:
Amendment 268 #
Proposal for a regulation Annex 3 – point d – introductory part (d) A European organisation representing
Amendment 269 #
Proposal for a regulation Annex 3 – point d – point i (i) is non-governmental, non-profit- making, representative, and independent of industry, commercial and business or other conflicting interests.
Amendment 270 #
Proposal for a regulation Annex 3 – point d – point i (i) is non-governmental, non-profit- making, representative and independent of industry, commercial and business or other conflicting interests.
Amendment 271 #
Proposal for a regulation Annex 3 – point d – point ii (ii) has as its statutory objectives and activities to represent social interests and vulnerable groups such as persons with disabilities in the standardisation process at European level;
Amendment 272 #
Proposal for a regulation Annex 3 – point d – point ii (ii) has as its statutory objectives and activities to represent social interests and in particular most vulnerable groups such as persons with disabilities in the standardisation process at European level;
Amendment 273 #
Proposal for a regulation Annex 3 – paragraph d – point ii (ii) has as its statutory objectives and activities to represent the social interests of vulnerable groups, such as persons with disabilities, in the standardisation process at European level;
Amendment 274 #
Proposal for a regulation Annex 3 – point d – point ii (ii) has as its statutory objectives and activities to represent
Amendment 275 #
Proposal for a regulation Annex 3 – point d – point iii (iii) has been mandated by national non- profit
Amendment 276 #
Proposal for a regulation Annex 3 – point d a (new) (da) A European organisation representing, in European standardisation activities, societal interests other from those referred to in points (b), (c) and (d), which: (i) is non-governmental, non-profit- making, and independent of industry, commercial and business or other conflicting interests. (ii) has as its statutory objectives and activities to represent societal interests in the standardisation process at European level; (iii) has been mandated by national non- profit societal organisations in at least two thirds of the Member States, to represent societal interests in the standardisation process at European level.
source: PE-480.857
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History
(these mark the time of scraping, not the official date of the change)
| activities/18 | added |
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| procedure/final | added |
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| procedure/stage_reached | changed |
Old
Procedure completed, awaiting publication in Official JournalNew
Procedure completed |
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