Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, 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, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council Text with EEA relevance
Modified by
- Directive 2014/28/EU of the European Parliament and of the Councilof 26 February 2014on the harmonisation of the laws of the Member States relating to the making available on the market and supervision of explosives for civil uses (recast)(Text with EEA relevance), 32014L0028, March 29, 2014
- Directive 2014/29/EU of the European Parliament and of the Councilof 26 February 2014on the harmonisation of the laws of the Member States relating to the making available on the market of simple pressure vessels(recast)(Text with EEA relevance), 32014L0029, March 29, 2014
- Directive 2014/31/EU of the European Parliament and of the Councilof 26 February 2014on the harmonisation of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments(recast)(Text with EEA relevance), 32014L0031, March 29, 2014
- Directive 2014/32/EU of the European Parliament and of the Councilof 26 February 2014on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments (recast)(Text with EEA relevance), 32014L0032, March 29, 2014
- Directive 2014/33/EU of the European Parliament and of the Councilof 26 February 2014on the harmonisation of the laws of the Member States relating to lifts and safety components for lifts(recast)(Text with EEA relevance), 32014L0033, March 29, 2014
- Directive 2014/34/EU of the European Parliament and of the Councilof 26 February 2014on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (recast)(Text with EEA relevance), 32014L0034, March 29, 2014
- Directive (EU) 2015/1535 of the European Parliament and of the Councilof 9 September 2015laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (codification)(Text with EEA relevance), 32015L1535, September 17, 2015
- Regulation (EU) 2022/2480 of the European Parliament and of the Councilof 14 December 2022amending Regulation (EU) No 1025/2012 as regards decisions of European standardisation organisations concerning European standards and European standardisation deliverables(Text with EEA relevance), 32022R2480, December 19, 2022
(1) "standard" means a technical specification, adopted by a recognised standardisation body, for repeated or continuous application, with which compliance is not compulsory, and which is one of the following: (a) "international standard" means a standard adopted by an international standardisation body; (b) "European standard" means a standard adopted by a European standardisation organisation; (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; (d) "national standard" means a standard adopted by a national standardisation body;
(2) "European standardisation deliverable" means any other technical specification than a European standard, adopted by a European standardisation organisation for repeated or continuous application and with which compliance is not compulsory; (3) "draft standard" means a document containing the text of the technical specifications concerning a given subject, which is being considered for adoption in accordance with the relevant standards procedure, as that document stands after the preparatory work and as circulated for public comment or scrutiny; (4) "technical specification" means a document that prescribes technical requirements to be fulfilled by a product, process, service or system and which lays down one or more of the following: (a) the characteristics required of a product including levels of quality, performance, interoperability, environmental protection, health, safety or dimensions, and 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; (b) production methods and processes used in respect of agricultural products as defined in Article 38(1) TFEU, products intended for human and animal consumption, and medicinal products, as well as production methods and processes relating to other products, where these have an effect on their characteristics; (c) the characteristics required of a service including levels of quality, performance, interoperability, environmental protection, health or safety, and including the requirements applicable to the provider as regards the information to be made available to the recipient, as specified in Article 22(1) to (3) of Directive 2006/123/EC; (d) the methods and the criteria for assessing the performance of construction products, as defined in point 1 of Article 2 of Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction productsOJ L 88, 4.4.2011, p. 5 .
(5) "ICT technical specification" means a technical specification in the field of information and communication technologies; (6) "product" means any industrially manufactured product and any agricultural product, including fish products; (7) "service" means any self-employed economic activity normally provided for remuneration, as defined in Article 57 TFEU; (8) "European standardisation organisation" means an organisation listed in Annex I; (9) "international standardisation body" means the International Organisation for Standardisation (ISO), the International Electrotechnical Commission (IEC) and the International Telecommunication Union (ITU); (10) "national standardisation body" means a body notified to the Commission by a Member State in accordance with Article 27 of this Regulation.
(a) the subject matter; (b) the stage attained in the development of the standards and European standardisation deliverables; (c) the references of any international standards taken as a basis.
(a) ensure access to draft national standards in such a way that all relevant parties in particular those established in other Member States have the opportunity to submit comments; (b) allow other national standardisation bodies to be involved passively or actively, by sending an observer, in the planned activities.
(a) the proposal and acceptance of new work items; (b) the technical discussion on proposals; (c) the submission of comments on drafts; (d) the revision of existing European standards or European standardisation deliverables; (e) the dissemination of information of, and awareness-building about, adopted European standards or European standardisation deliverables.
(a) identifying, in their annual work programmes, the standardisation projects, which are of particular interests to SMEs; (b) giving access to standardisation activities without obliging SMEs to become a member of a national standardisation body; (c) providing free access or special rates to participate in standardisation activities; (d) providing free access to draft standards; (e) making available free of charge on their website abstracts of standards; (f) applying special rates for the provision of standards or providing bundles of standards at a reduced price.
(a) decisions on the acceptance and refusal of standardisation requests; (b) decisions on the acceptance of new work items that are needed for the fulfilment of the standardisation request; and (c) decisions on the adoption, revision and withdrawal of European standards or European standardisation deliverables.
(a) to publish, not to publish or to publish with restriction the references to the harmonised standard concerned in the Official Journal of the European Union ;(b) to maintain, to maintain with restriction or to withdraw the references to the harmonised standard concerned in or from the Official Journal of the European Union .
(a) adopting the annual Union work programme for European standardisation referred to in Article 8(1); (b) adopting standardisation requests referred to in Article 10; (c) taking a decision on formal objections to harmonised standards, as referred to in Article 11(1); (d) taking a decision on identifications of ICT technical specifications referred to in Article 13; (e) adopting delegated acts referred to in Article 20.
(a) the development and revision of European standards or European standardisation deliverables which is necessary and suitable for the support of Union legislation and policies; (b) the verification of the quality, and conformity to the corresponding Union legislation and policies, of European standards or European standardisation deliverables; (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 without prejudice to the founding principles, especially the principles of openness, quality, transparency and consensus among all stakeholders; (d) the activities of the central secretariats of the European standardisation organisations, including policy development, the coordination of standardisation activities, the processing of technical work and the provision of information to interested parties; (e) the translation of European standards or European standardisation deliverables used in support of Union legislation and policies into the official Union languages other than the working languages of the European standardisation organisations or, in duly justified cases into languages other than the official Union languages; (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, strategies and training programmes; (g) activities seeking to carry out programmes of technical assistance, cooperation with third countries and the promotion and enhancement of the European standardisation system and of European standards and European standardisation deliverables among interested parties in the Union and at international level.
(a) national standardisation bodies for the standardisation activities referred to in paragraph 1, which they jointly undertake with the European standardisation organisations; (b) other bodies which have been entrusted with contributing to the activities referred to in point (a) of paragraph 1, or carrying out the activities referred to in points (c) and (g) of paragraph 1, in cooperation with the European standardisation organisations.
(a) the functioning of these organisations and of their activities relating to European and international standardisation, including the processing of technical work and the provision of information to members and other interested parties; (b) the provision of 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; (c) the participation in the technical work with respect to the development and revision of European standards and European standardisation deliverables which is necessary and suitable for the support of Union legislation and policies; (d) the promotion of European standards and European standardisation deliverables, and the information on, and use of, standards among interested parties, including SMEs and consumers.
(a) grants without a call for proposals, or contracts after public procurement procedures, to: (i) European standardisation organisations and national standardisation bodies to carry out the activities referred to in Article 15(1); (ii) bodies identified by a basic act, within the meaning of Article 49 of Regulation (EC, Euratom) No 1605/2002, to carry out, in collaboration with the European standardisation organisations the activities referred to in point (c) of Article 15(1) of this Regulation;
(b) grants after a call for proposals, or contracts after public procurement procedures, to other bodies referred to in point (b) of Article 15(2): (i) for contributing to the development and revision of European standards or European standardisation deliverables referred to in point (a) of Article 15(1); (ii) for carrying out the preliminary or ancillary work referred to in point (c) of Article 15(1); (iii) for carrying out the activities referred to in point (g) of Article 15(1);
(c) grants after a call for proposals to the European stakeholder organisations meeting the criteria set out in Annex III to this Regulation to carry out the activities referred to in Article 16.
(a) grants for actions; (b) operating grants for the European standardisation organisations and the European stakeholder organisations meeting the criteria set out in Annex III to this Regulation in accordance with the rules set out in Regulation (EC, Euratom) No 1605/2002. In the event of renewal, operating grants shall not be automatically decreased.
(a) European standards or European standardisation deliverables requested by the Commission in accordance with Article 10 are adopted or revised within a period not exceeding the period specified in the request referred to in that Article; (b) SMEs, consumer organisations and environmental and social stakeholders are appropriately represented and can participate in European standardisation activities, as referred to in Article 5(1).
(a) update the list of European standardisation organisations set out in Annex I to take into account changes in their name or structure; (b) 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 representativity. Such adaptations shall not have the effect of creating any new criteria or abolishing any existing criteria or category of organisation.
(a) the application of Articles 4, 5, 10, 15 and 17; (b) the representation of SMEs, consumer organisations and environmental and social stakeholders in national standardisation bodies; (c) the representation of SMEs on the basis of the annual reports referred to in Article 6(3); (d) the use of ICT in the standardisation system; (e) cooperation between the national standardisation bodies and European standardisation organisations.
(a) Article 6(1) of Directive 89/686/EEC; (b) Article 5 of Directive 93/15/EEC; (c) Article 6(1) of Directive 94/9/EC; (d) Article 6(1) of Directive 94/25/EC; (e) Article 6(1) of Directive 95/16/EC; (f) Article 6 of Directive 97/23/EC; (g) Article 14 of Directive 2004/22/EC; (h) Article 8(4) of Directive 2007/23/EC; (i) Article 7 of Directive 2009/23/EC; (j) Article 6 of Directive 2009/105/EC.
(a) in Article 1, paragraphs 6 to 10 are deleted; (b) Articles 2, 3 and 4 are deleted; (c) in Article 6(1), the words "with the representatives of the standards institutions referred to in Annexes I and II" are deleted; (d) in Article 6(3), the first indent is deleted; (e) in Article 6(4), points (a), (b) and (e) are deleted; (f) Article 7 is replaced by the following: "Article 7 Member States shall communicate to the Commission, in accordance with Article 8(1), all requests made to standards institutions to draw up technical specifications or a standard for specific products for the purpose of enacting a technical regulation for such products as draft technical regulations, and shall state the grounds for their enactment."; (g) in Article 11, the second sentence is replaced by the following sentence: "The Commission shall publish annual statistics on the notifications received in the Official Journal of the European Union .";(h) Annexes I and II are deleted.
(a) openness: the technical specifications were developed on the basis of open decision-making accessible to all interested parties in the market or markets affected by those technical specifications; (b) consensus: the decision-making process was collaborative and consensus based and did not favour any particular stakeholder. Consensus means a general agreement, characterised by the absence of sustained opposition to substantial issues by any important part of the concerned interests and by a process that involves seeking to take into account the views of all parties concerned and to reconcile any conflicting arguments. Consensus does not imply unanimity; (c) transparency: (i) all information concerning technical discussions and decision making was archived and identified; (ii) information on new standardisation activities was publicly and widely announced through suitable and accessible means; (iii) participation of all relevant categories of interested parties was sought with a view to achieving balance; (iv) consideration and response were given to comments by interested parties.
(a) maintenance: ongoing support and maintenance of published specifications are guaranteed over a long period; (b) availability: specifications are publicly available for implementation and use on reasonable terms (including for a reasonable fee or free of charge); (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, at the discretion of the intellectual property right-holder, licensing essential intellectual property without compensation; (d) relevance: (i) the specifications are effective and relevant; (ii) specifications need to respond to market needs and regulatory requirements;
(e) neutrality and stability: (i) specifications whenever possible are performance oriented rather than based on design or descriptive characteristics; (ii) specifications do not distort the market or limit the possibilities for implementers to develop competition and innovation based upon them; (iii) specifications are based on advanced scientific and technological developments;
(f) quality: (i) the quality and level of detail are sufficient to permit the development of a variety of competing implementations of interoperable products and services; (ii) standardised interfaces are not hidden or controlled by anyone other than the organisations that adopted the technical specifications.
(a) is non-governmental and non-profit-making; (b) has as its statutory objectives and activities to represent the interests of SMEs in the standardisation process at European level, to raise their awareness for standardisation and to motivate them to become involved in the standardisation process; (c) has been mandated by non-profit organisations representing SMEs in at least two thirds of the Member States, to represent the interests of SMEs in the standardisation process at European level.
(a) is non-governmental, non-profit-making, and independent of industry, commercial and business or other conflicting interests; (b) has as its statutory objectives and activities to represent consumer interests in the standardisation process at European level; (c) has been mandated by national non-profit consumer organisations in at least two thirds of the Member States, to represent the interests of consumers in the standardisation process at European level.
(a) is non-governmental, non-profit-making, and independent of industry, commercial and business or other conflicting interests; (b) has as its statutory objectives and activities to represent environmental interests in the standardisation process at European level; (c) has been mandated by national non-profit environmental organisations in at least two thirds of the Member States, to represent environmental interests in the standardisation process at European level.
(a) is non-governmental, non-profit-making, and independent of industry, commercial and business or other conflicting interests; (b) has as its statutory objectives and activities to represent social interests in the standardisation process at European level; (c) has been mandated by national non-profit social organisations in at least two thirds of the Member States, to represent social interests in the standardisation process at European level.
| Directive 98/34/EC | This Regulation |
|---|---|
| Article 1, first paragraph, point (6) | Article 2(1) |
| Article 1, first paragraph, point (7) | — |
| Article 1, first paragraph, point (8) | Article 2(3) |
| Article 1, first paragraph, point (9) | Article 2(8) |
| Article 1, first paragraph, point (10) | Article 2(10) |
| Article 2(1) | Article 3(1) |
| Article 2(2) | Article 3(2) |
| Article 2(3) | Article 3(3) and (4) |
| Article 2(4) | Article 27 |
| Article 2(5) | Article 20(a) |
| Article 3 | Article 4(1) |
| Article 4(1) | Article 3(3) and (5) and Article 4(4) |
| Article 4(2) | — |
| Article 6(3), first indent | — |
| Article 6(4)(a) | Article 20(a) |
| Article 6(4)(b) | — |
| Article 6(4)(e) | Article 10(2) |
| Annex I | Annex I |
| Annex II | Article 27 |
| Decision No 1673/2006/EC | This Regulation |
| Article 1 | Article 1 |
| Articles 2 and 3 | Article 15 |
| Article 4 | — |
| Article 5 | Article 17 |
| Article 6(1) | Article 18 |
| Article 6(2) | Article 24(3) |
| Article 7 | Article 19 |
| Decision 87/95/EEC | This Regulation |
| Article 1 | Article 2 |
| Article 2 | Article 3 |
| Article 3 | Article 13 |
| Article 4 | Article 8 |
| Article 5 | Article 14 |
| Article 6 | — |
| Article 7 | — |
| Article 8 | Article 24(3) |
| Article 9 | — |