49 Amendments of Christel SCHALDEMOSE related to 2011/0150(COD)
Amendment 70 #
Proposal for a regulation
Recital 4
Recital 4
(4) European standards play a very important role within the internal market, mainlyfor instance through the presumption of conformity of products to be made available on the market with the essential requirements of those products laid down in Union harmonisation legislation.
Amendment 71 #
Proposal for a regulation
Recital 4 a (new)
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)
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 74 #
Proposal for a regulation
Recital 7
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 77 #
Proposal for a regulation
Recital 7 a (new)
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)
Recital 7 b (new)
Amendment 82 #
Proposal for a regulation
Recital 12
Recital 12
(12) SThough standards primarily are market driven tools used on a voluntary basis by stakeholders, they can contribute significantly to helping European policy address the major societal challenges such as climate change, sustainable resource use, ageing, disability, consumer protection, workers' safety and conditions, social inclusion 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)
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
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 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.
Amendment 94 #
Proposal for a regulation
Recital 14
Recital 14
(14) European standards are of vital interest for the competitiveness of SMEs which, however, are in generalsome areas under- represented in standardisation activities, in particular at European level. Thus, this Regulation should ensurcourage and facilitate an appropriate representation and participation of SMEs in the European standardisation process by an entity with appropriate qualifications.
Amendment 95 #
Proposal for a regulation
Recital 15
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 societal stakeholdersall relevant stakeholders representing the public and societal interest in the elaboration of standards is strengthened, through the support of organisations representing the interests of consumers, workers, the environment and societal stakeholders.
Amendment 101 #
Proposal for a regulation
Recital 15 a (new)
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 105 #
Proposal for a regulation
Recital 15 d (new)
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 107 #
Proposal for a regulation
Recital 18
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. (See wording of paragraph 25 of the report of the European Parliament on the future of, by extending to the European Parliament, in addition, the right to object to a harmonised standard which does not, or does not entirely, cover all applicable essential requirements in the corresponding legislation, where this has been adopted in accordance with the ordinary legislative procedure. Or. en European standardisation (A7-0276/2010))
Amendment 108 #
Proposal for a regulation
Recital 28
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- profit organisations have given them, a European network representing non-profit bodies active in the Member States and promoting principles and policies consistent with the objectives of the Treaties. Because of the context in which they operate and their statutory objectives, European organisations representing SME, workers, consumers and environmental and social interests in European standardisation have a permanent role which is essential for Union activities and policies. Therefore, the Commission should be in a position to continue providing grants to those bodies without applying, in the case of operating grants, the principle of annual reduction referred to in Article 113(2) of Regulation (EC, Euratom) No 1605/2002.
Amendment 113 #
Proposal for a regulation
Article 1 – paragraph 1 a (new)
Article 1 – paragraph 1 a (new)
Amendment 114 #
Proposal for a regulation
Article 1 – paragraph 1 b (new)
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 131 #
Proposal for a regulation
Article 2 – paragraph 1 – point 2
Article 2 – paragraph 1 – point 2
(2) ‘European standardisation deliverable’ means any other technical specification than a European standard, adopted by a European standardisation bodyorganisation for repeated or continuous application and with which compliance is not compulsory;
Amendment 137 #
Proposal for a regulation
Article 2 – paragraph 1 – point 6
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; and in Directive 2006/123/EC1, in particular recital 22 and Article 2 (f). __________________ 1 OJ L, 27.12.2006
Amendment 140 #
Proposal for a regulation
Article 3 – paragraph 1
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 142 #
Proposal for a regulation
Article 4 – paragraph 1
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 147 #
Proposal for a regulation
Article 4 – paragraph 3 – point a
Article 4 – paragraph 3 – point a
(a) ensure access to the publication of draft national standards in such a way that partiesall relevant parties, in particular those established in other Member States, have the opportunity to submit comments;
Amendment 154 #
Proposal for a regulation
Article 5 – paragraph 1 – introductory part
Article 5 – paragraph 1 – introductory part
1. European sStandardisation bodies shall ensure an appropriate representation ofOrganisations shall encourage and facilitate an appropriate representation and participation of all relevant stakeholders, including market surveillance authorities, small and medium-sized enterprises (hereinafter ‘SME’), workers and consumer organisations and environmental and social stakeholders in their standardisation activities. They shall, in particular, do it 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 167 #
Proposal for a regulation
Article 5 – paragraph 1 c (new)
Article 5 – paragraph 1 c (new)
Amendment 169 #
Proposal for a regulation
Article 5 – paragraph 1 d (new)
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 171 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
2. European standardisation bodies shall ensurcourage and facilitate an appropriate representation and participation, at technical level, of undertakings, research centres and universities, market surveillance authorities in the Member States and other legal entities, in standardisation activities concerning an emerging area with significant policy or technical innovation implications, if the legal entities concerned participated in a project that is related to that area and that is funded by the Union under a multiannual framework programme for activities in the area of research and technological development.
Amendment 175 #
Proposal for a regulation
Article 5 a (new)
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 184 #
Proposal for a regulation
Article 6 – paragraph 1
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 187 #
Proposal for a regulation
Article 6 – paragraph 2 a (new)
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 190 #
Proposal for a regulation
Article 7 – paragraph 1
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 setreasonable deadline. They shall be market- driven, take into account the public interest and based on consensus. To that end, the request by the Commission shall be issued after consultation with the European Standardisation Organisations and relevant stakeholders participating in the Multi-stakeholder platform referred to in Article 18a.
Amendment 196 #
Proposal for a regulation
Article 7 – paragraph 3
Article 7 – paragraph 3
3. The Commission shall inform the relevant European standardisation body, within threone months following the receipt of the acceptance referred to in paragraph 2, about the award of a grant for drafting a European standard or European standardisation deliverable.
Amendment 198 #
Proposal for a regulation
Article 8 – paragraph 1
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. Or. en (See wording of paragraph 25 of the report of the European Parliament on the future of European standardisation (A7-0276/2010))
Amendment 202 #
Proposal for a regulation
Article 8 – paragraph 3 a (new)
Article 8 – paragraph 3 a (new)
Amendment 213 #
Proposal for a regulation
Article 9 – paragraph 1
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 decideMember States, a public authority or on its own initiative the Commission may decide, after consultation with the European Standardisation Organisations and the Multi-Stakeholder Platform on ICT Standardisation set up by the Commission Decision of 28 November 2011 (2011/C 349/04), 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 as a reference in public procurement.
Amendment 219 #
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
ICT standardtechnical specifications referred to in Article 9 of this Regulation shall constitute common technical specifications referred to in Directives 2004/17/CE and 2004/18/CE, and Regulation (EC) No 2342/2002.
Amendment 222 #
Proposal for a regulation
Article 11 – paragraph 1 – point b
Article 11 – paragraph 1 – point b
Amendment 223 #
Proposal for a regulation
Article 11 – paragraph 1 – point c
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 231 #
Proposal for a regulation
Article 11 – paragraph 1 – point f
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 243 #
Proposal for a regulation
Article 13 – paragraph 4 – point b
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 248 #
Proposal for a regulation
Article 16 – paragraph 1 a (new)
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
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 (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
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 detailed information on the following:
Amendment 254 #
Proposal for a regulation
Article 21 – paragraph 2
Article 21 – paragraph 2
Amendment 257 #
Proposal for a regulation
Annex 2 – point 2 – point a – paragraph 1
Annex 2 – point 2 – point a – paragraph 1
the technical specifications were developed on the basis of open decision-making accessible to all interested operatorparties in the market or markets affected by the standardtechnical specification.
Amendment 258 #
Proposal for a regulation
Annex 2 – point 2 – point c – point iii
Annex 2 – point 2 – point c – point iii
(iii) participation of all interested categories of interested stakeholderparties was sought with a view to achieving balance.
Amendment 267 #
Proposal for a regulation
Annex 3 – point d – introductory part
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 269 #
Proposal for a regulation
Annex 3 – point d – point i
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
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;