Home Europe European Commission Commission Implementing Decision (EU) 2023/2865 of 20 Decemb...
Date: 2023-12-21 Category: Not Applicable State: Union Government Country: Europe

Commission Implementing Decision (EU) 2023/2865 of 20 December 2023 setting up the INFRAFRONTIER European Research Infrastructure Consortium (INFRAFRONTIER ERIC) (notified under document C(2023) 8865)

Issued by European Commission · Directorate-General for Research and Innovation

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Executive Summary & Key Takeaways

Executive Summary: Commission Implementing Decision (EU) 2023/2865 establishes the INFRAFRONTIER European Research Infrastructure Consortium (INFRAFRONTIER ERIC). The decision, made on December 20, 2023, outlines the legal framework, tasks, and operational guidelines for the consortium, with Germany as the host Member State. It addresses Czech Republic, Germany, Greece, France, Finland and Sweden. Key Points / Main Content: * **Establishment and Legal Form:** * INFRAFRONTIER ERIC is established as a European Research Infrastructure Consortium. * It operates under Regulation (EC) No 723/2009, as amended by Regulation (EU) No 1261/2013. * **Statutory Seat:** * The statutory seat of INFRAFRONTIER ERIC is located in Munich, Germany. * **Tasks and Activities:** * INFRAFRONTIER ERIC's primary task is to establish and operate the INFRAFRONTIER Research Infrastructure (RI). * INFRAFRONTIER RI focuses on the generation, phenotyping, archiving, and distribution of in vivo/in vitro model systems and related data. * It coordinates access to resources and services for research on gene function in health and disease. * INFRAFRONTIER ERIC shall coordinate access to the resources and services provided by the Members and Observers or by any National Nodes. * It sets quality standards and promotes new technologies and serves as a contact point for stakeholders. * It must make freely available information on its activities. * INFRAFRONTIER ERIC operates on a non-profit basis, but may carry out limited economic activities. * **Duration and Winding Up:** * INFRAFRONTIER ERIC exists for an indefinite period. * Winding up requires a unanimous vote by the Assembly of Members. * The European Commission must be notified within 10 days of a decision to wind up. * Assets upon dissolution are to be transferred to a similar public or tax-privileged entity. * Data must be safely deposited to remain accessible and usable. * **Liability and Insurance:** * INFRAFRONTIER ERIC is liable for its debts. * Members' financial liability is limited to their annual contribution. * Appropriate insurance must be maintained. * **Access, Evaluation, and Dissemination Policies:** * Open access is the guiding principle for providing resources and services. * A strategic evaluation, including scientific and ethical aspects, must occur at least every five years by an independent external committee. * INFRAFRONTIER ERIC shall promote the use of the INFRAFRONTIER RI in research and education. * INFRAFRONTIER ERIC shall promote high quality research and support a culture of best practice through dissemination activities. * **Intellectual Property Rights (IPR):** * IPR of results created by INFRAFRONTIER ERIC's employees belongs to INFRAFRONTIER ERIC. * An IPR Policy must be adopted. * **Employment and Procurement Policies:** * INFRAFRONTIER ERIC is committed to transparency, equality, and non-discrimination in employment. * Procurement must be non-discriminatory and respect principles of transparency and competition. Impact Analysis: * **Member States (Czech Republic, Germany, Greece, France, Finland, and Sweden):** * *Impact:* These countries are directly addressed by the decision and are responsible for implementing and overseeing the operations of INFRAFRONTIER ERIC within their respective jurisdictions. * *Action Required:* Ensure alignment of national policies and regulations with the ERIC's statutes and actively participate in the governance and activities of the consortium. * **Research Community (Users of INFRAFRONTIER RI):** * *Impact:* Researchers gain access to resources, services, and data related to in vivo/in vitro model systems, facilitating research in gene function, health, and disease. * *Action Required:* Adhere to the Access Policy of INFRAFRONTIER ERIC, acknowledge the source of samples and data, and consider making research results publicly available through INFRAFRONTIER ERIC. * **INFRAFRONTIER ERIC Management and Staff:** * *Impact:* Responsible for the establishment, operation, and coordination of the INFRAFRONTIER RI, ensuring adherence to the statutes and policies outlined in the decision. * *Action Required:* Implement the tasks and activities defined in the statutes, including setting up access procedures, quality standards, and promoting new technologies. Manage intellectual property rights and ensure compliance with employment and procurement policies. * **European Commission:** * *Impact:* Oversees the implementation of the decision and ensures that INFRAFRONTIER ERIC operates in accordance with Regulation (EC) No 723/2009. * *Action Required:* Monitor the activities of INFRAFRONTIER ERIC, review strategic evaluations, and publish notices related to winding up procedures in the Official Journal of the European Union.

Key Entities Referenced

INFRAFRONTIER European Research Infrastructure Consortium INFRAFRONTIER ERIC: A European Research Infrastructure Consortium (ERIC) established to operate a distributed research infrastructure for the generation, phenotyping, archiving and distribution of in vivo/in vitro model systems and related data. Council Regulation EC No 723/2009: A European Union regulation establishing the Community legal framework for a European Research Infrastructure Consortium (ERIC). European Commission: The executive branch of the European Union, responsible for assessing the application to set up INFRAFRONTIER ERIC and ensuring it meets the requirements of Regulation EC No 723/2009. Czech Republic: One of the Member States that submitted the application to the Commission to set up INFRAFRONTIER ERIC. Federal Republic of Germany: One of the Member States that submitted the application to the Commission to set up INFRAFRONTIER ERIC, and the host Member State of INFRAFRONTIER ERIC. Hellenic Republic: One of the Member States that submitted the application to the Commission to set up INFRAFRONTIER ERIC. French Republic: One of the Member States that submitted the application to the Commission to set up INFRAFRONTIER ERIC. Republic of Finland: One of the Member States that submitted the application to the Commission to set up INFRAFRONTIER ERIC.
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Official Journal EN of the European Union L series 2023/2865 21.12.2023 COMMISSION IMPLEMENTING DECISION (EU) 2023/2865 of 20 December 2023 setting up the INFRAFRONTIER European Research Infrastructure Consortium (INFRAFRONTIER ERIC) (notified under document C(2023) 8865) (Only the Czech, Finnish, French, German, Greek and Swedish texts are authentic) (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Council Regulation (EC) No 723/2009 of 25 June 2009 on the Community legal framework for a European Research Infrastructure Consortium (ERIC)(1), and in particular Article 6(1), point (a), thereof, Whereas: (1) Czechia, Germany, Greece, France, Finland and Sweden submitted to the Commission an application in accordance with Article 5(1) of Regulation (EC) No 723/2009 to set up INFRAFRONTIER ERIC (‘the application’). (2) The applicants have agreed that Germany would be the host Member State of INFRAFRONTIER ERIC. (3) Regulation (EC) No 723/2009 has been incorporated in the Agreement on the European Economic Area (EEA) by Decision of the EEA Joint Committee No 72/2015(2). (4) The Commission has, pursuant to Article 5(2) of Regulation (EC) No 723/2009, assessed the application and concluded that it meets the requirements set out in that Regulation. In the course of the assessment, the Commission obtained the views of independent experts in the field of research of gene function in health and disease, and generation, phenotyping, archiving and distribution of in vivo/in vitro model systems and related data. (5) The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 20 of Regulation (EC) No 723/2009, HAS ADOPTED THIS DECISION: Article 1 1. The INFRAFRONTIER European Research Infrastructure Consortium (INFRAFRONTIER ERIC) is set up. 2. The essential elements of the Statutes of INFRAFRONTIER ERIC as referred to in Article 6(3) of Regulation (EC) No 723/2009 are set out in the Annex. Article 2 This Decision is addressed to the Czech Republic, the Federal Republic of Germany, the Hellenic Republic, the French Republic, the Republic of Finland and the Kingdom of Sweden. (1) OJ L 206, 8.8.2009, p. 1 (as amended by the Regulation (EU) No 1261/2013, OJ L 326, 6.12.2013, p. 1). (2) Decision of the EEA Joint Committee No 72/2015 of 20 March 2015 amending Protocol 31 to the EEA Agreement, on cooperation in specific fields outside the four freedoms [2016/755] (OJ L 129, 19.5.2016, p. 85). ELI: http://data.europa.eu/eli/dec_impl/2023/2865/oj 1/6EN OJ L, 21.12.2023 Done at Brussels, 20 December 2023. For the Commission Iliana IVANOVA Member of the Commission 2/6 ELI: http://data.europa.eu/eli/dec_impl/2023/2865/ojEN OJ L, 21.12.2023 ANNEX ESSENTIAL ELEMENTS OF THE STATUTES OF INFRAFRONTIER ERIC 1. Legal form and name (Article 1 of the Statutes of INFRAFRONTIER ERIC) A European Research Infrastructure Consortium shall be established. This Consortium shall have the legal form of a European Research Infrastructure Consortium (ERIC) incorporated under the provision of Regulation (EC) No 723/2009 as amended by the Regulation (EU) No 1261/2013 (hereinafter ‘the ERIC Regulation’) and be named ‘INFRAFRONTIER ERIC’. 2. Statutory seat and location (Article 2 of the Statutes of INFRAFRONTIER ERIC) The statutory seat of INFRAFRONTIER ERIC shall be located in Munich, Germany; hereinafter referred to as ‘Host Member State’. 3. Tasks and activities (Article 3 of the Statutes of INFRAFRONTIER ERIC) (1) The principal task of INFRAFRONTIER ERIC shall be to establish and operate a distributed research infrastructure, called ‘INFRAFRONTIER Research Infrastructure’, hereinafter referred to as ‘INFRAFRONTIER RI’. INFRAFRONTIER RI shall be the European Research Infrastructure for the generation, phenotyping, archiving and distribution of in vivo/in vitro model systems and related data. INFRAFRONTIER ERIC shall coordinate the operation of the distributed INFRAFRONTIER RI. (2) INFRAFRONTIER ERIC shall coordinate access to services and resources for the research of gene function in health and disease, using in vivo/in vitro model systems and related data. INFRAFRONTIER ERIC shall promote research, training and application in all fields of generating, phenotyping, archiving and distribution of disease models. (3) To this end INFRAFRONTIER ERIC shall: (a) Coordinate access to the resources and services provided by the Members and Observers of the INFRAFRONTIER ERIC or by any National Nodes that have entered into a legally binding agreement with INFRAFRONTIER ERIC to contribute to the resources and services of the INFRAFRONTIER RI; (b) Set up and deploy access procedures to the resources and services of INFRAFRONTIER RI that are in concordance with the respective European standards; (c) Set and adopt quality standards and standard operation procedures for the generation, phenotyping, archiving, distribution and data management of in vivo/in vitro model systems and related data; (d) Promote and coordinate the development of new technologies for the generation, phenotyping, archiving, distribution and data management of in vivo/in vitro model systems and related data to improve the scientific value of the INFRAFRONTIER RI’s resources and services; (e) Serve as contact point for national and international stakeholders of the INFRAFRONTIER RI; (f) Promote and publicise the resources and services of the INFRAFRONTIER RI and discuss the regulatory and policy aspects of the generation, phenotyping, archiving, distribution and data management of in vivo/in vitro model systems and related data; (g) Raise resources from national and international sources to facilitate INFRAFRONTIER RI activities; ELI: http://data.europa.eu/eli/dec_impl/2023/2865/oj 3/6EN OJ L, 21.12.2023 (h) Consult and advise national and international organisations working in the field of generating, phenotyping, archiving and distribution of in vivo/in vitro model systems; (i) Make freely available information on the activities of INFRAFRONTIER ERIC and the INFRAFRONTIER RI; and (j) Undertake any other activities necessary for achieving the tasks of INFRAFRONTIER ERIC. (4) INFRAFRONTIER ERIC shall pursue its principal task exclusively and directly on a non-profit basis and shall act altruistically and mainly on a non-economic basis. Without prejudice to State aid applicable rules, INFRAFRONTIER ERIC may carry out limited economic activities, provided that they are closely related to its principal task and that they do not jeopardise the achievement thereof. 4. Duration and the procedure for the winding up (Article 4 of the Statutes of INFRAFRONTIER ERIC) (1) INFRAFRONTIER ERIC shall exist for an indefinite period of time. (2) The winding up of INFRAFRONTIER ERIC shall be decided by the Assembly of Members by unanimous voting. If the Assembly of Members decides to wind up the INFRAFRONTIER ERIC, it shall, by simple majority vote, trigger the procedure for winding up. (3) The European Commission shall be notified without undue delay and in any event within 10 (ten) calendar days after adoption of the decision to wind up the INFRAFRONTIER ERIC. (4) Upon dissolution of INFRAFRONTIER ERIC, or in case the tax privileged purposes outlined in these Statutes no longer apply, the assets of INFRAFRONTIER ERIC exceeding the cash contributions and the actual value of the contributions in kind will be transferred to another public legal entity or another tax-privileged corporation, or to another legal entity pursuing objectives similar to those of INFRAFRONTIER ERIC for the promotion of science and research. (5) In the case of winding up, the INFRAFRONTIER ERIC shall ensure as far as possible that the data owned by INFRAFRONTIER ERIC shall be deposited safely so that such data remains accessible and usable in accordance with Article 6 of these Statutes as well as in accordance with the Data Policy and/or Access Policy, as applicable. (6) The European Commission shall be notified within 10 (ten) calendar days of the closure of the winding up procedure. INFRAFRONTIER ERIC shall cease to exist on the day on which the European Commission publishes the appropriate notice in the Official Journal of the European Union. 5. Liability regime and insurance (Article 5 of the Statutes of INFRAFRONTIER ERIC) (1) INFRAFRONTIER ERIC shall be liable for its debts. (2) The Members are not jointly and severally liable for the debts of INFRAFRONTIER ERIC. (3) The Members’ financial liability towards the INFRAFRONTIER ERIC’s debts shall be limited to their respective annual contribution as calculated according to the financial principles defined in the Article 25(2) of the Statutes and to the method of calculation defined in Annex 2 to these Statutes. (4) INFRAFRONTIER ERIC shall take appropriate insurance to cover the risks specific to the establishment and operation of INFRAFRONTIER ERIC. 4/6 ELI: http://data.europa.eu/eli/dec_impl/2023/2865/ojEN OJ L, 21.12.2023 6. Access Policy for users (Article 6 of the Statutes of INFRAFRONTIER ERIC) (1) The guiding principle for the provision of resources and services is open access. (2) Access will be given according to the Access Policy of the INFRAFRONTIER ERIC. Conditions set by sample and data providers to INFRAFRONTIER ERIC and recognized European principles for access to research infrastructures shall be respected. No provision in these Statutes shall be understood as seeking to restrict the right of owners of INFRAFRONTIER resources to decide on providing access to any samples or data. (3) INFRAFRONTIER ERIC shall seek to ensure that the source of samples and data is appropriately acknowledged and shall request that such attribution is maintained in subsequent use of the samples and data. 7. Scientific Evaluation Policy (Article 7 of the Statutes of INFRAFRONTIER ERIC) (1) The regular strategic evaluation of INFRAFRONTIER ERIC including scientific and ethical aspects shall be the task of an ad hoc independent external committee. (2) The Assembly of Members shall initiate such evaluations at least once every five years. The Assembly of Members shall nominate the members of such independent external committee and, if appropriate, give specific directions. Details concerning the nomination and operation will be specified in the Rules of Procedure. (3) Members of the independent external committee are acting under a personal title. 8. Dissemination Policy (Article 8 of the Statutes of INFRAFRONTIER ERIC) (1) INFRAFRONTIER ERIC shall promote the use of the INFRAFRONTIER RI in research and education. (2) INFRAFRONTIER ERIC shall promote high quality research and support a culture of ‘best practice’ through dissemination activities. (3) INFRAFRONTIER ERIC shall generally encourage researchers to make their research results publicly available and shall request users of the resources and services of the INFRAFRONTIER RI to make the results available through INFRAFRONTIER ERIC. (4) INFRAFRONTIER ERIC shall identify the various target groups and shall use several channels to reach the target audiences, such as web portals, newsletters, workshops, presence at conferences, articles in journals and daily newspapers. 9. Intellectual Property Rights Policy (Article 9 of the Statutes of INFRAFRONTIER ERIC) (1) In accordance with the objectives of the present Statutes the term ‘Intellectual Property’ will be understood according to article 2 of the Convention establishing the World Intellectual Property Organization signed on 14 July 1967. (2) Intellectual property rights of results created by INFRAFRONTIER ERIC’s employees shall belong to INFRAFRONTIER ERIC and shall be managed by the Managing Directors. ELI: http://data.europa.eu/eli/dec_impl/2023/2865/oj 5/6EN OJ L, 21.12.2023 (3) Use and collection of the INFRAFRONTIER ERIC’s data shall be subject to European and national laws of data privacy. (4) The intellectual property rights generated by users as a result of access to resources of INFRAFRONTIER ERIC shall be negotiated, aiming at a fair use by the user as well as by INFRAFRONTIER ERIC and/or the National Node concerned, taking into account their respective input. (5) An Intellectual Property Rights Policy shall be adopted in line with Article 20(11)(i) of these Statutes and shall contain further regulations concerning intellectual property rights. 10. Employment Policy (Article 10 of the Statutes of INFRAFRONTIER ERIC) (1) INFRAFRONTIER ERIC is committed to transparency and equality of opportunity and it shall not discriminate against any person on the grounds of race, ethnic origin, gender, creed, disability, sexual orientation or any other ground that is regarded as discrimination under the European Union law. (2) Recruitment of staff is fully open and international. 11. Procurement Policy (Article 11 of the Statutes of INFRAFRONTIER ERIC) (1) INFRAFRONTIER ERIC shall treat procurement candidates and tenders equally and in a non-discriminatory way, independent of whether or not they are based in the Union. (2) The INFRAFRONTIER ERIC’s procurement policy shall respect the principles of transparency, non-discrimination and competition. 6/6 ELI: http://data.europa.eu/eli/dec_impl/2023/2865/oj

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