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

CHAPTER I

GENERAL PROVISIONS

Article 1

Subject matter

This Regulation establishes rules with regard to the cooperation between European standardisation organisations, national standardisation bodies, Member States 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 identification of ICT technical specifications eligible for referencing, the financing of European standardisation and stakeholder participation in European standardisation.

Article 2

Definitions

For the purposes of this Regulation, the following definitions shall apply:

(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 products (¹), in relation to their essential characteristics;

(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.

CHAPTER II

TRANSPARENCY AND STAKEHOLDER PARTICIPATION

Article 3

Transparency of work programmes of standardisation bodies

The work programme shall indicate, in respect of each standard and European standardisation deliverable:

(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.

Article 4

Transparency of standards

National standardisation bodies shall:

(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.

Article 5

Stakeholder participation in European standardisation

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. They shall in particular encourage and facilitate such representation and participation through the European stakeholder organisations receiving Union financing in accordance with this Regulation at the policy development level and at the following stages of the development of European standards or European standardisation deliverables:

(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.

Article 6

Access of SMEs to standards

National standardisation bodies shall 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, for instance by:

(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.

Article 7

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 in accordance with Article 10.

CHAPTER III

EUROPEAN STANDARDS AND EUROPEAN STANDARDISATION DELIVERABLES IN SUPPORT OF UNION LEGISLATION AND POLICIES

Article 8

The annual Union work programme for European standardisation

Article 9

Cooperation with research facilities

The Commission’s research facilities shall contribute to the preparation of the annual Union work programme for European standardisation referred to in Article 8 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.

Article 10

Standardisation requests to European standardisation organisations

Without prejudice to other advisory opinions, each European standardisation organisation shall ensure that the following decisions concerning European standards and European standardisation deliverables referred to in paragraph 1 are taken exclusively by representatives of the national standardisation bodies within the competent decision-making body of that organisation:

(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.

Article 11

Formal objections to harmonised standards

When a Member State or the European Parliament considers that a harmonised standard or European standard drafted in support of Regulation (EU) 2023/988 does not entirely satisfy the requirements which it aims to cover and which are set out in the relevant Union harmonisation legislation or in that Regulation, it shall inform the Commission thereof with a detailed explanation. The Commission shall, after consulting the committee set up by the corresponding Union harmonisation legislation, if it exists, or the committee set up by that Regulation, or after other forms of consultation of sectoral experts, decide:

(a) to publish, not to publish or to publish with restriction the references to the harmonised standard or European standard concerned drafted in support of that Regulation in the Official Journal of the European Union; and

(b) to maintain, to maintain with restriction or to withdraw the references to the harmonised standard or European standard concerned drafted in support of that Regulation in or from the Official Journal of the European Union.

Article 12

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:

(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.

CHAPTER IV

ICT TECHNICAL SPECIFICATIONS

Article 13

Identification of ICT technical specifications eligible for referencing

Article 14

Use of ICT technical specifications in public procurement

The ICT technical specifications referred to in Article 13 of this Regulation shall constitute common technical specifications referred to in Directives 2004/17/EC, 2004/18/EC and 2009/81/EC, and Regulation (EC, Euratom) No 2342/2002.

CHAPTER V

FINANCING OF EUROPEAN STANDARDISATION

Article 15

Financing of standardisation organisations by the Union

The financing by the Union may be granted to the European standardisation organisations for the following standardisation activities:

(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.

The financing by the Union may also be granted to:

(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.

Article 16

Financing of other European organisations by the Union

The financing by the Union may be granted to the European stakeholder organisations meeting the criteria set out in Annex III to this Regulation for the following activities:

(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.

Article 17

Financing arrangements

Financing by the Union shall be provided in the form of:

(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.

The activities of the bodies referred to in paragraph 1 may be financed by:

(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.

Except in duly justified cases, grants awarded for the standardisation activities referred to in points (a) and (b) of Article 15(1) shall take the form of lump sums and for the standardisation activities referred to in point (a) of Article 15(1) shall be paid upon fulfilment of the following conditions:

(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).

Article 18

Management

The appropriations determined by the budgetary authority for the financing of standardisation activities may also cover the administrative expenses relating to the preparation, monitoring, inspection, auditing and evaluation which are directly necessary for the purposes of implementing Articles 15, 16 and 17, including studies, meetings, information and publication activities, expenses relating to informatics networks for the exchange of information and any other expenditure on administrative and technical assistance which the Commission may use for standardisation activities.

Article 19

Protection of the financial interests of the Union

CHAPTER VI

DELEGATED ACTS, COMMITTEE AND REPORTING

Article 20

Delegated acts

The Commission shall be empowered to adopt delegated acts in accordance with Article 21 concerning amendments to the Annexes, in order to:

(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.

Article 21

Exercise of the delegation

Article 22

Committee procedure