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ISSN 1977-091X |
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Official Journal of the European Union |
C 220 |
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English edition |
Information and Notices |
Volume 60 |
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Notice No |
Contents |
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II Information |
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INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
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European Commission |
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2017/C 220/01 |
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2017/C 220/02 |
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2017/C 220/03 |
ESSA hygiene guideline for the production of sprouts and seeds for sprouting |
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2017/C 220/04 |
Non-opposition to a notified concentration (Case M.8242 — Rolls-Royce/ITP) ( 1 ) |
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2017/C 220/05 |
Non-opposition to a notified concentration (Case M.8465 — Vivendi/Telecom Italia) ( 1 ) |
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2017/C 220/06 |
Non-opposition to a notified concentration (Case M.8510 — Robert Tönnies/Clemens Tönnies/Zur Mühlen Group and Asset Group) ( 1 ) |
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V Announcements |
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PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY |
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European Commission |
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2017/C 220/16 |
Prior notification of a concentration (Case M.8528 — SEGRO/PSPIB/SELP/Morgane Portfolio) — Candidate case for simplified procedure ( 1 ) |
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2017/C 220/17 |
Prior notification of a concentration (Case M.8557 — CCMP Capital/MSD Aqua Partners/Hayward Industries) — Candidate case for simplified procedure ( 1 ) |
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2017/C 220/18 |
Prior notification of a concentration (Case M.8356 — Wietersdorfer/Amiantit/HOBAS JV) ( 1 ) |
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(1) Text with EEA relevance. |
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EN |
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II Information
INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
European Commission
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8.7.2017 |
EN |
Official Journal of the European Union |
C 220/1 |
STATUTES OF CESSDA ERIC
(2017/C 220/01)
PREAMBLE
The Kingdom of Belgium,
The Czech Republic,
The Kingdom of Denmark,
The Federal Republic of Germany,
The Hellenic Republic,
The French Republic,
Hungary,
The Kingdom of the Netherlands,
The Republic of Austria,
The Republic of Slovenia,
The Slovak Republic,
The Kingdom of Sweden,
The United Kingdom of Great Britain and Northern Ireland,
The Kingdom of Norway,
Hereinafter referred to as ‘the Members’, and:
The Swiss Confederation,
Hereinafter referred to as ‘the Observers’,
WHEREAS the Members are convinced that the provision of access to social science data and metadata is vital to our understanding of the major challenges facing society today; ongoing societal processes, the problems involved and the solutions available.
WHEREAS the Consortium of European Social Science Data Archives (CESSDA) will build on existing national services within the member countries and strengthen and expand pan-European cooperation through close cooperation in the field of research and development in social science data archives for both scientific and economic reasons.
CONSIDERING that the Members seek to increase the scientific excellence and efficacy of European research in the social sciences as well as to expand easy access to data and metadata regardless of any borders.
RECALLING that CESSDA was recognized by the European Strategic Forum for Research Infrastructures (ESFRI) and was included in the ESFRI Roadmap (2006).
WHEREAS Germany is seeking to contribute additionally by financing special CESSDA tasks to be performed by the German Service Provider.
REQUESTING the European Commission to set up the infrastructure CESSDA as a European Research Infrastructure Consortium (CESSDA ERIC) under the Council Regulation (EC) No 723/2009 of 25 June 2009.
HAVE AGREED AS FOLLOWS:
CHAPTER 1
GENERAL PROVISIONS
Article 1
Name, Seat and Working Language
1. The Consortium of European Social Science Data Archives (CESSDA) shall have the legal form of a European Research Infrastructure Consortium (ERIC) set up under Regulation (EC) No 723/2009, called CESSDA ERIC.
2. CESSDA ERIC shall have its statutory seat in Bergen, Norway.
3. The working language of CESSDA ERIC is English.
Article 2
Task and Activities
1. CESSDA ERIC shall be the hub of a distributed research infrastructure linking together the social science data archives of the Members, Observers and other partners. CESSDA ERIC shall not operate its own data archives.
2. The task of CESSDA ERIC shall be to provide a distributed and sustainable research infrastructure enabling the research community to conduct high-quality research in the social sciences contributing to the production of effective solutions to the major challenges facing society today and to facilitate teaching and learning in the social sciences.
3. CESSDA ERIC shall operate on a non-economic basis. CESSDA ERIC may however carry out limited economic activities, provided that they are closely related to its main tasks and that they do not jeopardize the achievement of such tasks.
4. CESSDA ERIC shall fulfil its task by contributing to the development and coordination of standards, protocols and professional best practice including training on best practices related to data distribution and data management. CESSDA ERIC shall also include new data sources in the infrastructure when appropriate.
5. CESSDA ERIC shall promote wider participation in the research infrastructure. In order to facilitate the entry of countries that seek support for the further development of their social science data archives, CESSDA ERIC shall initiate training activities and exchanges between established and potential Service Providers.
CHAPTER 2
MEMBERSHIP
Article 3
Membership
1. The following entities may become Members or they can join as Observers without voting rights:
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(a) |
Member States of the Union; |
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(b) |
associated countries; |
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(c) |
third countries other than associated countries; |
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(d) |
intergovernmental organizations. |
Annex 1 to these Statutes contains a list of Members, Observers and Service Providers as of the date of the incorporation of CESSDA ERIC. This Annex shall be updated by the Director according to changes in the participation in CESSDA ERIC.
2. Accession of new Members and Observers and the withdrawal and termination of membership and status as Observer shall take place in accordance with Articles 5 and 6.
3. CESSDA ERIC shall have at least one Member State of the Union and two other countries that are either Member States of the Union or associated countries, as Members.
4. The rights of Members comprise the following rights:
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(a) |
to use CESSDA ERIC branding, consisting of all visual or sound representation of ‘CESSDA’ or ‘CESSDA ERIC’ linking the use of the words, a report, product or service to the CESSDA ERIC; |
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(b) |
to appoint one or more representing entities; |
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(c) |
to attend and vote at General Assembly meetings; |
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(d) |
to give Service Providers as defined in Article 11(2) the right to:
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(e) |
attend the Service Provider's Forum as provided for in Article 11. |
5. The obligations of Members shall be the following:
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(a) |
to contribute to the CESSDA ERIC budget in accordance with the funding formula set by the General Assembly; |
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(b) |
to designate a Service Provider that will provide CESSDA ERIC services in their country and across Europe; |
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(c) |
to provide national funding to allow the designated Service Provider to meet the requirements set out in Annex 2; |
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(d) |
to promote the adoption of standards in national social science data archives; |
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(e) |
to provide the technical infrastructures to make access to data and services possible; |
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(f) |
to promote uptake of services among researchers in the Member and gather user feedback and requirements; |
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(g) |
to support, and when needed, to initiate the integration of national social science data archives, including the integration between national archives and those in other Member or Observer countries. |
Article 4
Observers
1. An Observer shall be a country or intergovernmental organisation that is either preparing to become a Member, or which for domestic reasons cannot become a Member but wants to make a contribution and participate in the activities of CESSDA ERIC.
2. The rights of Observers comprise the following rights:
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(a) |
to use CESSDA ERIC branding with the phrase ‘Observer’; |
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(b) |
to appoint one or more representing entities; |
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(c) |
to attend General Assembly meetings, without a vote; |
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(d) |
to have access to direct support from CESSDA ERIC in developing their systems, processes and services; |
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(e) |
to give its Service Providers the right to:
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(f) |
attend the Service Providers' Forum as provided for in in Article 12. |
3. The obligations of the Observers shall be the following:
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(a) |
to make a contribution to the budget as decided by the General Assembly and as agreed as part of the application process; |
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(b) |
to undertake the activities that have been agreed when admitted as an Observer; |
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(c) |
to designate a Service Provider that will provide CESSDA ERIC services in their country and across Europe if these services have been agreed for the Observer in question; |
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(d) |
to provide national funding to allow the designated Service Provider, if any, to meet the requirements set out in Annex 2. |
Article 5
Accession
1. After the entry into force of these Statutes any entity listed in Article 3(1) may be admitted as Member or Observer. The accession shall be approved by a two-third majority of the votes cast of the General Assembly. A condition for accession shall be that the entity may contribute positively to the tasks and activities of CESSDA ERIC as referred to in Article 2, and can be expected to fulfil the obligations laid down in Articles 3(5) and 4(3). An application for membership or becoming an Observer shall be addressed to the Director who shall advise the General Assembly on whether the application should be granted or not.
2. Upon request of the Director, the acceding Member or Observer shall select and propose a Service Provider responsible for carrying out the Service Provider tasks.
3. The Director shall seek the advice of the Scientific Advisory Board and the Service Provider's forum before the proposed Service Provider is accepted or rejected.
Article 6
Withdrawal or Termination of Membership or status as Observer
1. Members and Observers may, by giving a minimum of six months' notice, withdraw from membership or from being Observers. The notice shall be in writing and be addressed to the Director. Members and Observers may not withdraw within the first four years of becoming Members or Observers, unless the General Assembly for exceptional reasons accepts a shorter period.
2. Any outstanding contributions shall be paid and other obligations shall be fulfilled before withdrawal of membership or status as Observer can become effective. Any assets belonging to the Service Provider funded by CESSDA ERIC shall where possible be handed back to CESSDA ERIC.
3. The General Assembly may decide by two-thirds majority of the votes cast to terminate the membership of a Member or the status as Observer if the Member or Observer violates the Statutes, the applicable legal regulations or is not able to meet the obligations for membership or the obligations of Observers.
4. A Member shall not have a vote in questions related to its own withdrawal or possible termination of membership.
CHAPTER 3
GOVERNANCE
Article 7
Governance
1. The governance structure of CESSDA ERIC shall consist of the following bodies:
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(a) |
the General Assembly; |
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(b) |
the Director; |
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(c) |
the Service Providers and the Service Providers' Forum, which has an advisory role; |
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(d) |
the Scientific Advisory Board; |
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(e) |
any other advisory committee established by the General Assembly to facilitate the fulfilment of the objectives of CESSDA ERIC. |
Article 8
The General Assembly
1. The General Assembly shall consist of delegates of Members and Observers.
2. The General Assembly shall be the ultimate authority of CESSDA ERIC. The General Assembly shall carry out the following functions:
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(a) |
decide the budget and funding formula, and approve the annual accounts and annual report. Any change in the funding formula shall require a two-thirds majority of votes cast. Any increase in the budget that leads to a higher yearly fee shall be decided by a two-thirds majority of the votes cast; |
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(b) |
determine CESSDA ERIC's policy in scientific, technical and administrative matters and establish and maintain an intellectual property policy, by a two-thirds majority of the votes cast; |
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(c) |
adopt strategic plans and work plans, by a two-thirds majority of the votes cast; |
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(d) |
supervise the management of CESSDA ERIC; |
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(e) |
elect the Chair and Vice Chair of the General Assembly; |
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(f) |
appoint and dismiss the Director of CESSDA ERIC; |
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(g) |
appoint, replace and remove members of the Scientific Advisory Board; |
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(h) |
approve Service Providers, proposed by a Member or an Observer, and approve the replacement of Service Providers. The approval may be withdrawn if the Service Provider does not fulfil its obligations; |
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(i) |
appoint, replace and remove any members of committees that the General Assembly has established; |
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(j) |
adopt audit Reports for CESSDA ERIC; |
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(k) |
receive and consider annual reports from the Scientific Advisory Board; |
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(l) |
adopt the operational rules and standards for CESSDA ERIC related operations of the Service Providers, in consultation with the Service Providers' Forum; |
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(m) |
approve the accession of new Members and Observers, and the withdrawal or termination of Members or Observers in accordance with Articles 5 and 6; |
3. Each Member shall be represented in the General Assembly by up to two delegate(s). Each Member shall have a single vote in the General Assembly. Decisions shall be taken by a simple majority of the votes cast, unless otherwise laid down in these Statutes. Member States of the Union and associated countries shall jointly hold the majority of the voting rights in the General Assembly. The Chair shall not have a vote, except in the case of a tie, where the Chair shall hold a casting vote.
4. A quorum of half of the Members shall be required for having a valid General Assembly meeting. If there is no quorum, the meeting shall be repeated within three weeks following a new invitation, with the same agenda. In the repeat meeting there shall be a quorum if at least a quarter of the Members are present. If there is no quorum at the repeat meeting the Chair of the General Assembly shall be entitled to adopt decisions that cannot be postponed until the General Assembly can convene once again with a quorum. Such decisions shall be presented to the General Assembly for review at the first possible occasion.
5. If the Statutes require a two-thirds majority vote, a quorum of three-quarters of the Members shall be necessary for a valid decision.
6. A vote in the General Assembly can only be cast by members physically present. However, if a member is not able to be physically present, the General Assembly may accept an electronic presence. Voting rights shall not be transferable. A secret ballot shall be held if at least one third of the members present request such a procedure.
7. The Chair may, when necessary, resolve that a decision is to be taken by written procedure in between meetings of the General Assembly.
8. Observers shall have the right to attend meetings of the General Assembly, without the right to vote. Each Observer may send up to two delegates.
9. The General Assembly shall elect a Chair and a Vice Chair amongst the delegations of the Members for a period of two years. When elected, the Chair shall no longer be part of a Member's delegation. The same shall apply when the Vice Chair replaces the Chair. The Members affected by these appointments shall appoint another delegate to represent them in the General Assembly.
10. The General Assembly shall meet at least once a year. Meetings of the General Assembly shall be convened by the Chair with at least four weeks' notice. Members and Observers shall be entitled to propose items to be included in the agenda by notifying the Chair at least two weeks before the meeting. Extraordinary meetings of the General Assembly shall be convened at the request of the Chair or the Director if it is required in the interest of CESSDA ERIC, or at the request of at least half of the Members.
Article 9
The Director
1. The Director shall be the chief executive officer, chief scientific officer and legal representative of CESSDA ERIC.
2. The Director shall be appointed for a five-year period and may be re-appointed. The Director shall report to the General Assembly.
3. The Director shall be responsible for preparing the annual budget, strategies and policies, to be adopted by the General Assembly.
4. The Director shall be responsible for preparing meetings of the General Assembly and shall give the Scientific Advisory Board and the Service Providers' Forum the necessary administrative support.
5. The Director shall be responsible for implementing the General Assembly's decisions and shall ensure that CESSDA ERIC observes all relevant legal requirements.
6. The Director shall be empowered to make all decisions necessary for the operation of CESSDA ERIC.
7. The Director shall regularly seek the advice of the Service Providers' Forum in matters of particular interest for the Service Providers, by inviting the Service Provider's Forum to comment on the draft budget, work-plans and strategies and other important policy matters before they are submitted to the General Assembly.
8. The Director shall monitor the adherence of the Service Providers to the operational rules and standards for CESSDA ERIC related operations and report annually to the General Assembly with recommendations for counter measures for any irregularities.
Article 10
The Scientific Advisory Board
1. The General Assembly shall appoint an independent Scientific Advisory Board of at least four, but not more than seven eminent, independent and experienced scientists coming from countries worldwide. The appointment of the Scientific Advisory Board shall be based on recommendations from the Director. The Director shall seek advice from the Scientific Advisory Board and the Service Providers' Forum. The term of office of the members of the Scientific Advisory Board shall be three years. Members may be reappointed once.
2. The Director shall consult with the Scientific Advisory Board at least once a year on the scientific quality of the services, scientific policies and procedures and future plans within these fields.
3. The Scientific Advisory Board shall annually submit a written report to the General Assembly through the Director on its activities. The report shall contain an assessment of the services offered by CESSDA ERIC to its data users. The Director shall submit the report to the General Assembly together with the Director's comments and possible recommendations.
4. The Scientific Advisory Board may request the Director to propose to the General Assembly to supplement the members of the Board to ensure that it is sufficiently representative of all areas covered by CESSDA ERIC.
Article 11
Service Providers
1. The Service Providers shall constitute the operational distributed network integrated by CESSDA ERIC.
2. Service Providers shall be institutions designated by the Members and Observers pursuant to Articles 3(5)(b) and 4(3)(c) to undertake tasks related to acquiring, curating and providing access to social science data in their country and across Europe.
3. Service Providers shall adhere to the operational rules and standards for CESSDA ERIC related operations as set out in Annex 2.
4. The rights and obligations of CESSDA ERIC and the Service Providers related to the tasks listed in Annex 2 shall be governed by Service Level Agreements between CESSDA ERIC and the Service Provider in question.
5. The Service Providers partake in the governance of CESSDA ERIC in an advisory capacity.
6. Service Providers' ability to fulfil their obligations as provided for in Annex 2 shall be assessed every second or third year according to the decision of the General Assembly. The Director, in consultation with the Service Providers' Forum and the Scientific Advisory Board, shall decide how and by whom the assessments are to be conducted, and shall present the General Assembly with the results of the assessments together with proposals for the General Assembly's resolutions related to them.
Article 12
Service Providers' Forum
1. The Service Providers' Forum shall consist of representatives of the Service Providers and shall have an advisory function. Each Member or Observer may have one member in the Forum. The Service Providers' Forum shall be facilitated and supported by the Director.
2. The Director shall consult with the Service Providers' Forum at least once a year on the future plans and technical aspects of CESSDA ERIC activities and convey the opinions of the Service Providers to the General Assembly.
Article 13
Amendments to the Statutes
The General Assembly may with a two-thirds majority of the votes cast decide to propose an amendment to the Statutes. The proposal shall be submitted to the European Commission in accordance with Article 11 of Regulation (EC) No 723/2009.
CHAPTER 4
POLICIES
Article 14
Data Access Policy
1. The Data Access Policy of CESSDA ERIC shall be in conformity with OECD recommendations and guidelines on data access (OECD Principles and Guidelines for Access to Research Data from Public Funding, OECD 2007).
2. Publicly funded data and metadata held by the Service Providers shall, unless provided otherwise for in Article 14(6), be openly accessible and free at the point of access for public research and education and shall be made available in a timely fashion.
3. All data collections shall be made available by Service Providers for access to authorised researchers for public research and education.
4. Service Providers shall protect the anonymity of data subjects in accordance with applicable international, European and national regulations, as well as relevant ethical frameworks.
5. Service Providers shall maintain fair, open and transparent procedures regarding access to the data and metadata in their custody.
6. The principle of open access provided for in Articles 14(2) and 14(3) shall not oblige a Service Provider to share data, metadata or data collections if this would be in conflict with national legislation, intellectual property rights or other compelling legal reasons.
Article 15
Dissemination Policy
1. CESSDA ERIC's Dissemination Policy shall be implemented through its communications strategy.
2. The Dissemination Policy shall cover the outputs of all activities funded by CESSDA ERIC and shall be openly available except where pre-existing intellectual property rights make this impossible.
3. All technical papers, policies, core procedures, monitoring reports, shall be publicly available on the CESSDA ERIC website.
4. All documentation relating to meeting the obligations of being a Service Provider shall be published by the Service Providers.
Article 16
Intellectual Property
1. The term ‘intellectual property’ shall in these Statutes be understood in accordance with Article 2 of the Convention Establishing the World Intellectual Property Organisation (WIPO) signed on 14 July 1967.
2. With respect to questions of intellectual property, the relations between Members, Observers and Service Providers shall be governed by applicable national as well as relevant international rules and regulations.
3. Intellectual property that Members or Service Providers contribute to CESSDA ERIC shall remain the property of the intellectual property holder.
4. If the intellectual property originates from CESSDA ERIC-funded work (direct contribution or in kind), such property shall belong to CESSDA ERIC. CESSDA ERIC may relinquish its rights fully or partially in favour of the Member, Observer or Service Provider that has created the intellectual property rights.
Article 17
Employment
1. CESSDA ERIC shall adhere to the principles of equal opportunity employment. Scientific positions shall be filled after having been announced internationally.
2. Subject to the requirements of national legislation, each Member within its jurisdiction shall make its best endeavours to facilitate the movement and residence of nationals of the Member involved in the tasks of the CESSDA ERIC and of the family members of such nationals.
CHAPTER 5
FINANCE AND LIABILITY
Article 18
Contributions
The General Assembly shall set the contribution for each Member based on the budget and, save for special contributions, in proportion to the individual Member's GDP. The contributions shall be transferred to CESSDA ERIC within the date set by the General Assembly. The General Assembly shall set the contributions for Observers.
Article 19
Budgetary Principles, Accounts and Audits
1. The financial year shall be a calendar year.
2. The Director shall prepare and submit to the General Assembly for approval a draft annual budget and business plan, including proposed contributions from Members and Observers. The annual budget, and contributions due, shall be approved by the General Assembly at least six months before the coming financial year. The annual budget shall be balanced so that the planned expenses shall not exceed the planned income.
3. CESSDA ERIC shall be subject to the rules of the host country's accounting legislation to ensure the preparation, filing, auditing and publication of the accounts in accordance with generally accepted international accounting principles and principles of transparency.
4. CESSDA ERIC shall produce an annual activity report. That report shall contain in particular the scientific, operational and financial aspects of CESSDA ERIC activities. The report shall be approved by the General Assembly and be transmitted to the European Commission and relevant public authorities within six months from the end of the corresponding financial year. This report shall be made publicly available.
Article 20
Finance, Liability and Insurance
1. The resources of CESSDA ERIC shall consist of:
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(a) |
financial contributions from Members and Observers; |
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(b) |
possible host contributions; |
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(c) |
other resources, within limits and under terms approved by the General Assembly, including research grants from national or international sources, donations and any income from economic activities. |
2. CESSDA ERIC shall be liable for its debts.
3. The Members and Observers are not jointly liable for the debts of CESSDA ERIC.
4. CESSDA ERIC shall take appropriate insurance to cover risks specific to the construction and operation of the CESSDA ERIC infrastructure.
Article 21
Procurement and Tax Exemption
1. CESSDA ERIC shall treat procurement candidates and tenderers equally and without discrimination, regardless whether or not they are based within the European Union. The procurement policy shall respect the principles of transparency, non-discrimination and competition.
2. Procurement by Members and Observers concerning CESSDA ERIC activities shall be done in such a way that due consideration is given to CESSDA ERIC needs, and shall be in accordance with technical requirements and specifications issued by the relevant CESSDA ERIC body.
3. Tax exemptions based on Norwegian Act relating to value added tax of June 2009 No 58, § 10-3, shall be limited to the value added tax for such goods and services which are for official and exclusive use by CESSDA ERIC and are wholly paid and procured by CESSDA ERIC. The tax exemptions shall apply to non-economic activities. They shall not apply to economic activities. No further limits shall apply.
CHAPTER 6
DURATION, WINDING UP, DISPUTES, SET UP PROVISIONS
Article 22
Duration
CESSDA ERIC shall exist until it is wound up in accordance with Article 22(2).
Article 23
Winding up
1. The General Assembly may by a two-thirds majority of the votes cast decide to wind up CESSDA ERIC.
2. Without undue delay and in any event within 10 days after adoption of the decision to wind up, CESSDA ERIC shall notify the European Commission about the decision.
3. Assets remaining after payment of the CESSDA ERIC debts shall be apportioned among the Members in proportion to their accumulated contributions to CESSDA ERIC.
4. Without undue delay and in any event within 10 days of the closure of the winding up procedure, CESSDA ERIC shall notify the Commission thereof.
5. CESSDA 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.
Article 24
Applicable law
The setting up and the functioning of the CESSDA ERIC shall be governed by:
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(a) |
Union law, in particular Regulation (EC) No 723/2009; |
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(b) |
the host country's law in the case of matters not, or only partly, regulated by Union law; |
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(c) |
these Statutes and their implementing rules. |
Article 25
Disputes
1. The Court of Justice of the European Union shall have jurisdiction over litigation among the Members and Observers in relation to CESSDA ERIC, between the Members and Observers and CESSDA ERIC and over any litigation to which the European Union is party.
2. Union legislation on jurisdiction shall apply to disputes between CESSDA ERIC and third parties. In cases not covered by Union legislation, the host country's law shall determine the competent jurisdiction for the resolution of the dispute and the choice of law.
3. The legal venue for any case against CESSDA ERIC shall be the district court of Bergen unless otherwise follows from Article 24 and 25(2).
Article 26
Availability of the Statutes
These Statutes shall be kept up to date and made publicly available on the CESSDA ERIC website and at the statutory seat.
ANNEX 1
List of Members and Observers and their Representing entities and Service Providers
Members:
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Country: |
Representing entity: |
Service Provider: |
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Norway |
Research Council of Norway |
Norsk senter for forskningsdata AS |
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Austria |
Federal Ministry of Science, Research and Economy (BMWFW) |
AuSSDA — The Austrian Social Science Data Archive |
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Belgium |
BELSPO, EWI, D.G.E.N.O.R.S. (1) |
Social Sciences and Humanities Data Archive — SOHDA |
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Czech Republic |
Ministry of Education, youth and Sports |
The Czech Social Science Data Archive |
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Denmark |
Danish Agency for Science and Higher Education |
Danish Data Archive — DDA |
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France |
National Center for Scientific Research (CNRS) |
Progedo |
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Germany |
Federal Ministry of Education and Research BMBF |
Leibniz-Institute for the Social Sciences (GESIS) |
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Greece |
Greek research Infrastructure for the social sciences – So.Da.Net (2) |
Greek research Infrastructure for the social sciences – So.Da.Net |
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Hungary |
The National Research, Development and Innovation Office (NRDI Office) |
TÁRKI Foundation |
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The Netherlands |
The Netherlands Organisation for Scientific Research (NWO) |
Data Archiving and Networked Services — DANS |
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Slovakia |
Ministry of Education, Science, Research and Sport of the Slovak Republic |
Slovak Archive of Social Data — SASD |
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Slovenia |
Ministry of Education, Science and Sport, MIZŠ |
Social Science Data Archives — ADP |
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Sweden |
Swedish Research Council |
Swedish National Data service — SND |
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United Kingdom |
Economic and Social Research Council, ESRC |
UK Data Service |
Observers:
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Country: |
Representing entity: |
Service Provider: |
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Switzerland |
Swiss Centre of expertise in the Social Sciences |
FORS |
(1) BELSPO: Service public de programmation Politique scientifique.
EWI: Departement Economie, Wetenschap en Innovatie
D.G.E.N.O.R.S.: Direction générale de l’Enseignement non obligatoire et de la Recherche scientifique.
(2) The annual fee for the member will be paid by the National Centre for Social Research EKKE.
ANNEX 2
Service Providers' Obligations
CESSDA Service Providers shall have the following obligations:
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1. |
be compliant with the agreed elements of the DDI metadata standard that are required to enable the member/observer to contribute to CESSDA ERIC activities and which will be identified by CESSDA ERIC; |
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2. |
adopt and apply the common single sign-on user authentication system(s) recommended by CESSDA ERIC; |
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3. |
enable the harvesting of their resource discovery metadata and relevant additional metadata for inclusion in the CESSDA ERIC data portal; |
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4. |
make their data holdings downloadable through common data gateways as far as permitted by the relevant legislation and regulations; |
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5. |
ensure that the applicable national language(s) within the multi-lingual thesaurus are maintained; |
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6. |
share their data archiving tools (under the intellectual property conditions provided for in Article 16 of the Statutes); |
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7. |
adhere to the principles of the Open Archival Information System reference model and any agreed CESSDA ERIC requirements for operating trusted repositories; |
|
8. |
contribute to CESSDA ERIC's cross national data harmonisation activities; |
|
9. |
contribute material and/or expertise to the cross-national question bank; |
|
10. |
provide mentor support for CESSDA ERIC Observers and their representative Service Providers to achieve full Membership; |
|
11. |
provide member support for countries with immature and fragile national infrastructures to help them build up needed competence later to be able to fulfil tasks as Members; |
|
12. |
facilitate access to national government and research funded relevant data, dependent on national legal systems; |
|
13. |
adhere to CESSDA ERIC's Data Access and Dissemination Policies; |
|
14. |
adhere to the provisions of CESSDA ERIC policies as required. |
ANNEX 3
Budget and Members' contributions
This Annex sets out the mechanism of calculating of the contributions by Members and Observers.
(a) Budget 2017 - 2019
The estimated CESSDA ERIC Budget for the period 2017 - 2019 is based on the continuation of the previous CESSDA Consortium agreement, and is based on an annual Membership fee contribution of EUR 1,9 million (based on 13 Members).
The distribution of the Membership fee is as follows:
|
1. |
Special contributions
|
|
2. |
A total fee of EUR 350 000 is distributed amongst the other Members/Observers of CESSDA ERIC according to principles defined in the Statutes Article 18. |
|
3. |
In case of CESSDA ERIC having fewer members/observers than 13 for the first three years after being established, the budget line Membership fee will be topped up by reserves that will be transferred to the CESSDA ERIC from the previous consortium (CESSDA AS). |
|
4. |
In case of CESSDA ERIC having additional members/observers, they will be paying proportionate, annual contributions calculated separately and added to the total contribution. |
(b) Budget 2020-2021
The budget for the period 2020 and onwards should be based on an estimated Membership fee contribution of EUR 1,5 million.
The distribution of the Membership fee is as follows:
|
1. |
Special contributions
|
|
2. |
A total fee of EUR 390 000 is distributed amongst the other Members/Observers of CESSDA ERIC according to principles defined in Article 18. |
|
3. |
In case of CESSDA ERIC having additional members/observers, they will be paying proportionate, annual contributions calculated separately and added to the total contribution. |
(c) Principles for allocation of members' contributions
In accordance with Article 8, the General Assembly shall set the contribution for each Member based on the budget and, save for Members making special contributions, in proportion to the individual Member's GDP. The General Assembly shall set the contributions for Observers.
The source data for the calculation of fees for Members and Observers making a proportionate annual contribution is the World Bank indicator ‘GDP (current USD)’, for the most recent year figures are available for all Members at the time of making the calculation.
Norway and Germany shall make special contributions. All other Members/Observers shall make proportionate annual contributions. The total value of the proportionate annual contributions is calculated to achieve the total target budget after taking into account the special annual contributions.
The membership contribution of intergovernmental organisations shall be decided by the General Assembly on a case-by-case basis.
(d) Calculation of the 2016 budget
The 2016 budget has a total Membership fee of EUR 1 932 737, based on 15 Members and 1 Observer.
|
Member |
GDP (2014) (USD) |
Annual Contribution (EUR) |
|
Austria |
436 343 622 435 |
16 478 |
|
Belgium |
533 382 785 676 |
20 142 |
|
Czech Republic |
205 522 871 251 |
7 761 |
|
Denmark |
341 951 607 730 |
12 913 |
|
Finland |
270 673 584 162 |
10 222 |
|
France |
2 829 192 039 172 |
106 841 |
|
Germany |
3 852 556 169 656 |
750 000 |
|
Greece |
237 592 274 371 |
8 972 |
|
Lithuania |
48 172 242 517 |
1 819 |
|
Netherlands |
869 508 125 480 |
32 836 |
|
Norway |
500 103 094 419 |
800 000 |
|
Slovakia |
99 790 145 653 |
3 768 |
|
Slovenia |
49 416 055 609 |
1 866 |
|
Sweden |
570 591 266 160 |
21 548 |
|
Switzerland |
701 037 135 966 |
26 474 |
|
United Kingdom |
2 941 885 537 461 |
111 096 |
|
Total |
14 487 718 557 718 |
1 932 737 |
The calculations for the coming years shall be undertaken as soon as the necessary GDP figures are available.
|
8.7.2017 |
EN |
Official Journal of the European Union |
C 220/15 |
STATUTES OF ECCSEL ERIC
European Carbon Dioxide Capture and Storage Laboratory — European Research Infrastructure Consortium
(2017/C 220/02)
Table of contents
| Preamble | 15 |
|
1. |
General provisions | 16 |
|
2. |
Membership | 16 |
|
3. |
Rights and obligation of the Members and Observers | 18 |
|
4. |
Governance of ECCSEL ERIC | 19 |
|
5. |
Finance | 22 |
|
6. |
Reporting to the European Commission | 22 |
|
7. |
Policies | 23 |
|
8. |
Duration, amendments to the Statutes, winding up, disputes | 25 |
ANNEXES
| Annex I List of Members and Observers | 27 |
| Annex II Budget contribution and distribution | 28 |
PREAMBLE
France, Italy, the Netherlands, Norway and the United Kingdom, hereinafter referred to as the ‘Members’
WHEREAS the States mentioned above cooperating in order to establish a ‘European Carbon Dioxide Capture and Storage Laboratory Infrastructure’, hereinafter referred to as ECCSEL, are convinced that anthropogenic carbon dioxide emissions is a global climate challenge that calls for international cooperation;
CONSCIOUS that the challenge makes both, emission reductions as well as the capture, transport and safe storage of carbon dioxide necessary;
CONSIDERING that analyses made by the Intergovernmental Panel on Climate Change (IPCC) and the International Energy Agency (IEA) suggest that by 2050, Carbon Capture and Storage (CCS) must ensure up to 17 % of the global annual CO2 emission cuts, and 14 % of the accumulated cuts from now on and that CCS will require commercial uptake starting in 2020-2030 and continuing beyond 2030;
KNOWING that these demands can only be met by intensified research and development aimed to enhance the scientific and technological knowledge base;
RECOGNISING the need for close international cooperation in the field of research and development related to CCS for both scientific and economic reasons;
ACKNOWLEDGING that national research infrastructures can benefit from international advice in the field of CCS and the operation of and investment in facilities for such research
CONSIDERING that ECCSEL is justified by the need for a dedicated and coordinated research environment, striving to close specific knowledge gaps, pushing the forefront of technological development beyond the state-of-the-art, and thereby accelerating the commercialisation and deployment of CCS methods;
BELIEVING that ECCSEL is needed to ensure the efficient use of existing research infrastructure and to coordinate infrastructure investments, thereby contributing to cost effectivity at a European scale;
WHEREAS the Members request the European Commission to set up ECCSEL as a European Research Infrastructure Consortium (ERIC) under the Council Regulation (EC) No 723/2009 (1),
HAVE AGREED AS FOLLOWS:
CHAPTER 1
GENERAL PROVISIONS
Article 1
Name, seat, location and working language
1. There shall be a distributed European Research Infrastructure Consortium called the ‘European Carbon Dioxide Capture and Storage Laboratory — European Research Infrastructure Consortium’, hereinafter referred to as ‘ECCSEL ERIC’.
2. ECCSEL ERIC shall have its statutory seat in Trondheim, Norway.
3. The working language of ECCSEL ERIC is English.
Article 2
Tasks and activities
1. ECCSEL ERIC shall establish and operate a world-class distributed research infrastructure to be set up as a central hub responsible for the coordinated operation of several facilities operating under a joint hallmark, ECCSEL ERIC.
|
a) |
ECCSEL ERIC shall coordinate the use of the research facilities in the distributed infrastructure and coordinate plans for their upgrade and new investments. ECCSEL ERIC shall assure the international open access to the infrastructure. ECCSEL ERIC shall furthermore, within its means and competence, support the owners of the research facilities in their endeavours to enhance the operations of their facilities and their endeavours to upgrade them and to create new facilities. |
|
b) |
ECCSEL ERIC shall facilitate superior experimental research on new and improved CO2 capture, transport and storage techniques (CCS), envisaging commercial uptake by 2020-2030 and beyond 2030, respectively. The General Assembly may in the future decide on an extension of ECCSEL ERIC activities towards utilisation of CO2 (Carbon Capture, Utilisation, and Storage (CCUS)) beyond enhanced oil recovery (EOR). |
|
c) |
ECCSEL ERIC does not own and operate research facilities itself. The General Assembly may however in the future decide that ECCSEL ERIC shall invest in or run its own facilities. Members and Observers who do not wish to participate in funding such facilities may abstain from the financing of them in accordance with Article 9(2)(a). |
2. ECCSEL ERIC shall make facilities required for conducting research in priority areas available for the international research community. By doing this ECCSEL ERIC will contribute to pushing the forefront of technological development beyond the current state-of-the-art, thereby accelerating the commercialisation and deployment of CCS. In this undertaking, ECCSEL ERIC shall address and nurture top-level research actions among scientists within the field of CCS and according to the priorities of ECCSEL ERIC. ECCSEL ERIC will establish a very advanced inventory of unique research facilities and give the European CCS community (primarily), and non-European CCS communities access to these resources.
3. ECCSEL ERIC shall be constructed and operated on a non-economic basis.
4. Without prejudice to Article 2(3), ECCSEL ERIC may carry out limited economic activities provided that they are closely related to ECCSEL ERIC's main tasks and they do not jeopardise the achievement thereof.
CHAPTER 2
MEMBERSHIP
Article 3
Membership and representing entity
1. The following entities may become Members of ECCSEL ERIC, or they may become Observers, in accordance with the rights and obligations referred to in Articles 6 and 7:
|
a) |
Member States of the European Union; |
|
b) |
associated countries; |
|
c) |
third countries other than associated countries; |
|
d) |
intergovernmental organisations. |
Conditions for admission of Members and Observers are specified in Articles 4(1) and 4(2) of these Statutes.
2. ECCSEL ERIC shall have at least one Member State and two other Members that are either Member States or associated countries.
3. Any Member or Observer, according to its own rules and procedures, may appoint one public entity or one private entity with a public service mission, by which the Member or Observer will be represented.
4. The current Members, Observers and their representing entities are listed in Annex I. Annex I shall be updated by the Director according to changes in the participation in ECCSEL ERIC.
Article 4
Admission of Members and Observers
1. The terms for admission of new Members shall be the following:
|
a) |
the admission of new Members requires the unanimous approval of the General Assembly; |
|
b) |
applicants must submit a written application to the Director of ECCSEL ERIC; |
|
c) |
the application must at least describe how the applicant will contribute to ECCSEL objectives and activities described in Article 2 and how it will fulfil obligations referred to in Article 6(2). |
2. Entities listed in Article 3(1) that are willing to contribute to ECCSEL ERIC, but are not in a position to join as Members, may apply for Observer status. The terms for admission of Observers shall be the following:
|
a) |
Observers may be admitted for a period of three years. In exceptional cases the General Assembly may approve a longer period for the Observer status; |
|
b) |
an entity that foresees a lasting participation in ECCSEL ERIC, but that for domestic reasons is not in a position to become a Member, may in exceptional cases be granted the status of Permanent Observer; |
|
c) |
the admission or readmission of Observers requires the unanimous approval of the General Assembly; |
|
d) |
applicants must submit a written application to the Director; |
|
e) |
the application must at least describe how the applicant will contribute to ECCSEL ERIC tasks and activities described in Article 2 and how it will fulfil obligations referred to in Article 7(2). |
Article 5
Withdrawal of a Member or an Observer and termination of Membership or Observer status
1. A Member or an Observer may withdraw from ECCSEL ERIC at the end of a financial year provided that it notifies its intention to withdraw by sending an official request 12 months in advance to the Chair of the General Assembly.
|
a) |
Members may not withdraw within the first five years of becoming Members. |
|
b) |
Any outstanding fees must be paid and any obligations towards ECCSEL must be met before a withdrawal is confirmed. The withdrawing Member or Observer shall only pay the fees due respectively under Articles 6(2) and 7(2) at the date of its withdrawal with no additional cost or penalty. |
2. The General Assembly may terminate the membership of a Member or the Observer status of an Observer if the following conditions are met:
|
a) |
the Member or Observer is in serious breach of one or more of its obligations under these Statutes; |
|
b) |
the Member or Observer has failed to rectify such breach within a period of six months after receipt of the notification of breach from the General Assembly. |
The Member or Observer shall be given opportunity to contest the decision of termination and to present its defence to the General Assembly within a period of three months after receipt of the notification of termination. Such termination shall not affect any obligations of a Member or Observer incurred prior to the date of termination.
CHAPTER 3
RIGHTS AND OBLIGATIONS OF THE MEMBERS AND OBSERVERS
Article 6
Members
1. Members of ECCSEL ERIC shall have the right to:
|
a) |
appoint representing entities in accordance with Article 3(3); |
|
b) |
have for its research community access to the ECCSEL ERIC resources and all its services in conformity with the Access Policy referred to in Article 18; |
|
c) |
attend the General Assembly; |
|
d) |
vote at the General Assembly, in accordance with Article 9(3); |
|
e) |
participate in the development of strategies and policies; |
|
f) |
have its research community participating in ECCSEL ERIC events, such as workshops, conferences and training courses, at preferential rates; |
|
g) |
use the ECCSEL ERIC brand, in particular for the operators of the ECCSEL ERIC facilities. The brand consists of all visual or sound representation of ‘ECCSEL’ or ‘ECCSEL ERIC’ linking the user of the words, a report, product or a service to the ECCSEL ERIC. |
2. Members of ECCSEL ERIC shall:
|
a) |
pay the annual fee as specified in Annex II within the given time-limit; |
|
b) |
provide at least one agreed research facility; |
|
c) |
promote uptake of ECCSEL ERIC services among researchers in their country, and gather user feedback and requirements; |
|
d) |
support and, when appropriate, attempt to initiate the integration of national facilities and the integration between national facilities and those in other Member or Observer states. |
Article 7
Observers
1. Observers of ECCSEL ERIC shall have the right to:
|
a) |
appoint representing entities in accordance with Article 3(3); |
|
b) |
attend the General Assembly without voting rights; |
|
c) |
have its research community participating in ECCSEL ERIC events, such as workshops, conferences, training courses at preferential rates, space permitting; |
|
d) |
have access for its research community to support from ECCSEL ERIC in developing relevant systems, processes and services. |
2. Observers of ECCSEL ERIC shall pay the annual fee as specified in Annex II. The General Assembly may decide an initial Observer fee different from the normal fee.
3. Permanent Observers, who are granted this status in accordance with Article 4(2)(b) shall have the same rights and obligations as Members, listed in Articles 6(1) and 6(2), except the right to vote at the General Assembly, referred to in Article 6(1)(d).
CHAPTER 4
GOVERNANCE OF ECCSEL ERIC
Article 8
The governance and operational structure of ECCSEL ERIC
1. The governance structure of ECCSEL ERIC shall consist of:
|
a) |
The General Assembly; |
|
b) |
The Director; |
|
c) |
The Research Infrastructure Coordination Committee; |
|
d) |
The Scientific Advisory Board; |
|
e) |
The Ethics and Environmental Advisory Board; |
|
f) |
Any other advisory Committee established by the General Assembly to facilitate the fulfilment of the objectives of ECCSEL ERIC. |
2. The operational structure of ECCSEL ERIC shall consist of:
|
a) |
The Operations Centre, which will be ECCSEL ERIC's main office and location of the ECCSEL ERIC management; |
|
b) |
The nationally owned research facilities which participate in the ECCSEL ERIC distributed infrastructure; |
|
c) |
The national infrastructure Nodes representing the research facilities within a country in accordance with Article 11(1). |
Article 9
The General Assembly
1. The General Assembly shall consist of the Members and Observers of ECCSEL ERIC.
2. The General Assembly is the ultimate authority of ECCSEL ERIC. The General Assembly shall:
|
a) |
set the budget, the funding formula and the annual fees. Any change in the funding formula and annual fees made during the first five years as specified in Annex II, shall require a unanimous vote of the General Assembly. After the initial five years such changes shall require a two-thirds majority vote. A Member or Observer who does not wish to participate in the funding of possible future ECCSEL ERIC owned or run facilities, must declare so before the General Assembly makes its decisions to own or operate such facilities, and will then not be obliged to take part in the funding of the facility; |
|
b) |
determine ECCSEL ERIC's policy in scientific, technical and administrative matters. These policies are to be adopted with a two-thirds majority vote; |
|
c) |
adopt strategic plans and work plans for ECCSEL ERIC, by a two-thirds majority vote; |
|
d) |
supervise the management of ECCSEL ERIC; |
|
e) |
elect the Chair and Vice Chair of the General Assembly, by a two-thirds majority vote; |
|
f) |
appoint, replace and remove the Director of ECCSEL ERIC, by a two-thirds majority vote; |
|
g) |
appoint, replace and remove Members of the Scientific Advisory Board, and the Ethics and Environmental Advisory Board, by a two-thirds majority vote; |
|
h) |
appoint, replace and remove any Members of Committees that the General Assembly has established, by a two-thirds majority vote; |
|
i) |
nominate or validate on an annual basis the financial auditor; |
|
j) |
adopt the annual reports of ECCSEL ERIC, including the accounts and the audit report for the financial year, by a two-thirds majority vote; |
|
k) |
receive and consider annual reports from the Research Infrastructure Coordination Committee and the Scientific Advisory Board; |
|
l) |
approve the admission of new Members and Observers, and the termination of membership or status as Observer. Approval of new Members and Observers shall require a unanimous decision by the General Assembly. A Member shall not have a vote in the question of a possible termination of its own membership; |
|
m) |
decide which nationally owned research facilities may participate in ECCSEL ERIC and which facilities shall cease to do so. A Member or an Observer may withdraw a facility from ECCSEL ERIC activities. A list of the facilities that participate in ECCSEL ERIC shall be updated continuously by the Director; |
|
n) |
approve agreements with third parties as provided for in Article 15, by a two-thirds majority vote. |
3. Each Member and Observer shall be represented in the General Assembly by up to two delegates. A Member shall have a single vote in the General Assembly. Observers shall not have a vote. Decisions shall be taken by majority voting unless otherwise determined in these Statutes. Member States and associated countries shall jointly hold the majority of the voting rights in the General Assembly. The Chair shall not have a vote, except in the case of a tie, where the Chair shall hold a casting vote.
4. A quorum of two thirds of the Members is required for having a valid General Assembly. If there is not a quorum, the meeting shall be repeated within three weeks following a new invitation, with the same agenda. In the repeat meeting there is a quorum if at least a quarter of the Members are present. If there is not a quorum at the repeat meeting the Chair of the General Assembly shall be entitled to make decisions that cannot be postponed until the General Assembly can convene once again with a quorum. Such decisions shall be reviewed by the General Assembly at the first possible occasion.
5. A vote in the General Assembly may only be casted by Members physically represented. If a Member is not able to be physically represented, the General Assembly may accept an electronic presence. Voting rights may not be transferred. A secret ballot shall be held if at least one third of the Members present request such a procedure.
The Chair of the General Assembly may, when necessary, resolve that a decision is to be taken by written procedure in between meetings of the General Assembly.
6. The General Assembly shall elect its Chair and Vice Chair amongst the delegates for a period of two years. When elected the Chair may no longer be part of a Member's delegation to the General Assembly. The same applies when the Vice Chair replaces the Chair. The Members affected by these appointments may appoint another delegate to represent them in the General Assembly.
7. The General Assembly shall meet at least once a year. Meetings of the General Assembly shall be convened by the Chair with at least three weeks' notice. Members and Observers are entitled to propose items to be included in the agenda by notifying the Chair at least two weeks before the meeting.
8. Extraordinary meetings of the General Assembly may be convened at the request of the Chair or the Director if it is required in the interest of the Organisation, or at the request of at least half of the Members.
Article 10
The Director
1. The Director shall be the chief executive officer, chief scientific officer and legal representative of ECCSEL ERIC.
2. The Director shall be appointed for a five-year period and may be re-appointed once. The vacancy of the position shall be published internationally in an appropriate manner. The Director shall report to the General Assembly. The Director may not serve as a delegate or Chair of the General Assembly.
3. The Director shall be responsible for preparing the meetings of the General Assembly, and shall give the Research Infrastructure Coordination Committee, the Scientific Advisory Board and the Ethics and Environmental Advisory Board the necessary administrative support.
4. The Director shall responsible for preparing the annual budget for ECCSEL ERIC, and for preparing strategies and policies, to be adopted by the General Assembly.
5. The Director shall responsible for implementing the General Assembly's decisions, including the implementation of the budget, and shall ensure that ECCSEL ERIC observes all relevant legal requirements.
6. The Director shall be empowered to make all decisions necessary for the operation of ECCSEL ERIC except those decisions that are the prerogatives of the General Assembly.
7. The Director shall seek the support and advice of the Research Infrastructure Coordination Committee in matters of particular interest for owners of the infrastructure facilities, including inviting the Committee to comment on the draft budget, work-plans and strategies before they are submitted to the General Assembly.
8. The Director shall monitor the adherence of the owners of the research facilities to the operational rules and standards for ECCSEL ERIC related operations that have been determined by the General Assembly and report annually on this matter to the General Assembly with recommendations for counter measures for any irregularities.
Article 11
The Research Infrastructure Coordination Committee, the Scientific Advisory Board and the Ethics and Environmental Advisory Board
1. The Research Infrastructure Coordination Committee
|
a) |
The Research Infrastructure Coordination Committee shall have a supportive and advisory function and shall consist of representatives of the ECCSEL Facilities and the Director, who chairs the Committee. The Committee shall elect a Vice Chair for a period of three years. Re-election is possible once. Each Member and Observer may have one representative in the Committee. Countries that have two or more ECCSEL facilities shall appoint one of the facilities' operator as the national representative, and this institution will represent the country's national facilities in the Committee. Delegates to the General Assembly cannot be a representative in this Committee. |
|
b) |
The task of the Research Infrastructure Coordination Committee is to strengthen the cooperation between the facilities and their contributions to experimental research. This will be done by overseeing the implementation of ECCSEL ERIC's strategies and plans, by contributing to them, and by proposing measures that can enhance the functioning of ECCSEL ERIC. |
|
c) |
The Director shall consult with the Committee on all proposals to be submitted to the General Assembly relating to strategic plans, work plans and budgets. The Committee shall support the Director in the execution of strategic plans and work plans. |
|
d) |
The Research Infrastructure Coordination Committee shall annually submit a written report to the General Assembly, through the Director, on its activities. The Director shall submit the report to the General Assembly together with the Director's comments and possible recommendations. |
2. The Scientific Advisory Board
|
a) |
The General Assembly shall appoint an independent Scientific Advisory Board of up to six eminent, independent and experienced scientists coming from countries worldwide. The appointment of the members of the Scientific Advisory Board shall be based on suggestions from the Director, who shall seek advice from the Scientific Advisory Board and from the Research Infrastructure Coordination Committee. The term of office of the Members of the Scientific Advisory Board is three years. Re-appointment is possible once. Delegates to the General Assembly cannot be appointed to this Board. |
|
b) |
The Director shall consult with the Scientific Advisory Board at least once a year on the scientific quality of the services offered by ECCSEL ERIC, the organisation's scientific policies, procedures and future plans. |
|
c) |
The Scientific Advisory Board shall annually submit a written report to the General Assembly, through the Director, on its activities. The Director shall submit the report to the General Assembly together with the Director's comments and possible recommendations. |
3. The Ethics and Environmental Advisory Board
|
a) |
The General Assembly will appoint the independent Ethics and Environmental Advisory Board of three to five eminent, independent and experienced scientists coming from countries worldwide. The appointment of the Board shall be based on suggestions from the Director, who shall seek advice from the Ethics and Environmental Advisory Board and the Research Infrastructure Coordination Committee. The term of office of the Members of the Board is three years. Re-appointment is possible once. Delegates to the General Assembly cannot be appointed to this Board. |
|
b) |
The Director shall consult with the Ethics and Environmental Advisory Board at least once a year on ethical and environmental issues facing ECCSEL ERIC at present or in the future. |
|
c) |
The Ethics and Environmental Advisory Board shall annually submit a written report to the General Assembly, through the Director, on its activities. The Director shall submit the report to the General Assembly together with the Director's comments and possible recommendations. |
CHAPTER 5
FINANCE
Article 12
Budgetary principles and accounts
1. The financial year of ECCSEL ERIC begins on 1 January and ends on 31 December of each year.
2. All items of revenue and expenditure of ECCSEL ERIC shall be included in estimates to be drawn up for each financial year and shall be shown in the annual budget. The annual budget shall be in compliance with the principles of transparency.
3. The accounts of ECCSEL ERIC are to be accompanied by a report on budgetary and financial management of the financial year.
4. ECCSEL ERIC shall be subject to the requirements of the applicable law as regards preparation, filing, auditing and publication of accounts. ECCSEL ERIC shall apply the rules in the host country's accounting legislation in accordance with generally accepted international accounting principles and principles of transparency.
5. ECCSEL ERIC shall use the appropriations in accordance with the principles of sound financial management.
6. ECCSEL ERIC shall record the costs and revenues of its economic activities separately.
7. In-kind contributions shall be considered only when in the form of effective and quantifiable contribution to the ECCSEL ERIC, including seconded personnel to ECCSEL ERIC Operations Centre, and agreed by the General Assembly.
8. The value of any in-kind contributions shall be taken into account when calculating the monetary contributions provided during the same period.
Article 13
Liability
1. ECCSEL ERIC shall be liable for its debts.
2. The Members shall not be jointly liable for the debts of ECCSEL ERIC. The liability of the Members for the debts of ECCSEL ERIC shall be limited to their respective contributions.
3. ECCSEL ERIC shall take appropriate insurance to cover the risks specific to the construction and operation of ECCSEL ERIC.
CHAPTER 6
REPORTING TO THE EUROPEAN COMMISSION
Article 14
Reporting to the European Commission
1. ECCSEL ERIC shall produce an annual activity report, containing in particular the scientific, operational and financial aspects of its activities. The report is to be approved by the General Assembly and transmitted to the European Commission and relevant public authorities within six months from the end of the corresponding financial year. This report shall be made publicly available.
2. ECCSEL ERIC shall inform the European Commission of any circumstances which threaten to seriously jeopardise the achievement of ECCSEL ERIC principal tasks or hinder ECCSEL ERIC from fulfilling requirements laid down in Regulation (EC) No 723/2009.
CHAPTER 7
POLICIES
Article 15
Agreements with third parties
1. In cases where ECCSEL ERIC deems it beneficial, and in conformity with the tasks and activities described in Article 2, it may enter into agreement with third parties, such as e.g. individual institutions, regions and non-Member countries.
2. If third parties as described in Article 15.1 wish to contribute to ECCSEL ERIC with expertise, services, and technology, ECCSEL ERIC may enter into an agreement with such third parties. The agreement shall specify a service or other contribution which the third party will deliver, and specify access rights, the subscription fee and other conditions in the light of this contribution. Third parties' users of ECCSEL facilities may be obliged to take part in the ECCSEL ERIC authentication and authorisation system.
Article 16
Procurement policy and tax exemption
1. ECCSEL ERIC shall treat procurement candidates and tenderers equally and in a non-discriminatory way, independent of whether or not they are based in the European Union. The ECCSEL ERIC procurement policy shall respect the principles of transparency, non-discrimination and competition.
2. The Director shall be responsible for all ECCSEL ERIC procurement. The decision to award procurement shall be published appropriately and include a full justification. The General Assembly shall adopt Implementing Rules defining all necessary details on exact procurement procedures and criteria.
3. Procurement by Members and Observers concerning ECCSEL ERIC activities shall be done in such a way that due consideration is given to ECCSEL ERIC needs, technical requirements and specifications issued by the relevant bodies.
4. Tax exemptions based on Norwegian Act relating to value added tax of 19 June 2009 No 58, § 10-3, shall be limited to the value added tax for such goods and services which are for official and exclusive use by ECCSEL ERIC and are wholly paid and procured by ECCSEL ERIC or by Members States of ECCSEL ERIC. The tax exemptions shall apply to non-economic activities. They shall not apply to economic activities. No further limits shall apply.
5. If a Member State of ECCSEL ERIC is tasked with hosting an ECCSEL ERIC Office which is recognised by that Member State of ECCSEL ERIC as an international body in the sense of Articles 143(1)(g) and 151(1)(b) of Council Directive 2006/112/EC (2) and as an international organisation in the sense of Article 12(1)(b) of Council Directive 2008/118/EC (3), that ECCSEL ERIC Office shall in regard to goods and services acquired within the EU for its own needs or to accomplish the tasks it has been attributed by ECCSEL ERIC benefit from tax exemptions based on Articles 143(1)(g) and 151(1)(b) of Directive 2006/112/EC, exceed the value of EUR 300, and are wholly paid and procured by ECCSEL ERIC or by Members of ECCSEL ERIC. The tax exemptions shall apply to non-economic activities. They shall not apply to economic activities. No further limits shall apply.
Article 17
Employment
1. ECCSEL ERIC shall be an equal opportunity employer. The procedures for selecting applicants for ECCSEL ERIC staff positions shall be transparent, non-discriminatory and respect equal opportunities.
2. Employment contracts shall be subject to applicable laws and regulations of the country in which the staff is employed or to the laws of the country where the activities of ECCSEL ERIC are conducted. ECCSEL ERIC vacancies shall be published internationally in an appropriate manner.
3. Subject to the requirements of national legislation, each Member shall within its jurisdiction facilitate the movement and residence of nationals of Members involved in the tasks of ECCSEL ERIC and of the family members of such nationals.
Article 18
Access Policy
1. A substantial part of the available research time for each national facility participating in the ECCSEL infrastructure is to be offered to the international research community. The General Assembly shall reserve a proportion of the access time available to researchers from states that are not Members of ECCSEL ERIC.
2. ECCSEL ERIC and the owners of the research facilities shall enter into individual agreements related to how large a proportion of the available research time will be made available for the international research community and the conditions for access.
3. The access to ECCSEL ERIC facilities shall be open to researchers, scientists and students. The granting of access is to be based on competition and peer review of applications after a fair and transparent procedure. The criteria for the competition shall be scientific excellence and importance in relation to ECCSEL ERIC strategies, as decided by the General Assembly.
4. Users shall bear all access costs and all costs related to materials including samples and equipment belonging to such users. The access costs shall be based on rates applying to each ECCSEL ERIC Facility.
5. ECCSEL ERIC may establish a system for authentication and authorisation that ensures that only persons that are entitled to access a facility are admitted entry and use. ECCSEL ERIC may decide that Members and Observers must adhere to such a system if their researchers are to be granted access.
6. A detailed Access Policy applicable to users, approved by the General Assembly, is to be publically available.
Article 19
Dissemination policy
1. There shall be open access to ECCSEL ERIC research results and data in accordance with the dissemination policy adopted by the General Assembly. The research results and data shall be given to interested parties without payment of other costs than those associated with the dissemination. For the purpose of this provision, ‘ECCSEL ERIC research results and data’ shall mean research results and data in the field of carbon dioxide capture and storage generated by the owners of the facilities that participate in the ECCSEL ERIC infrastructure.
2. ECCSEL ERIC shall actively disseminate ECCSEL ERIC research results to society so that they can play an active role in policy development and the control of carbon dioxide emissions.
3. ECCSEL ERIC shall promote the ECCSEL ERIC cooperation and the cooperation's results, encourage researchers to embark on new and innovative projects and, as appropriate, encourage researchers to use ECCSEL ERIC results in their higher education.
4. ECCSEL ERIC shall generally encourage users of ECCSEL ERIC research results to make their own research results publicly available and shall request users to make suitable publicity about the access provided to them within ECCSEL ERIC.
5. The dissemination policy shall describe the various target groups, and use several channels to reach the target audiences. In all publications dealing with results and knowledge generated by or within the ECCSEL cooperation, ECCSEL ERIC shall be duly acknowledged.
Article 20
Intellectual property rights policy
1. In accordance with the objects of the present Statutes, the term ‘Intellectual Property’ is to be understood according to Article 2 of the Convention Establishing the World Intellectual Property Organisation (WIPO) signed on 14 July 1967.
2. With respect to questions of Intellectual Property, the relations between the Members are to be governed by the national legislation of the Member countries, as well as relevant international rules and regulations.
3. Intellectual property that Members provide to ECCSEL ERIC shall remain the property of the original Intellectual Property holder. If such property originates from ECCSEL ERIC funded work (direct contribution or in kind), the intellectual property shall belong to ECCSEL ERIC, unless it has been agreed that the property shall belong to the Member that has created it. The possible economic value of access above the fee paid shall not be regarded as ECCSEL ERIC funding of a project.
4. ECCSEL ERIC shall ensure that users agree to the terms and conditions governing access to results and intellectual property rights of results and that suitable security arrangements are in place regarding the storage and handling of rights and results.
5. ECCSEL ERIC shall have in place arrangements for investigating allegations of security breaches and confidentiality disclosures regarding research data and information.
6. ECCSEL ERIC shall provide guidance to researchers to ensure that research undertaken using material made accessible through ECCSEL ERIC shall be undertaken within a framework that recognises the rights of owners.
7. A detailed Intellectual Property Rights Policy, approved by the General Assembly shall be separately agreed by the parties operating the facilities that participate in the ECCSEL ERIC infrastructure.
CHAPTER 8
DURATION, AMENDMENTS TO THE STATUTES, WINDING-UP, DISPUTES
Article 21
Duration
ECCSEL ERIC shall be established for an indefinite period of time.
Article 22
Amendment to the Statutes
The General Assembly may decide to change the Statutes. Any change of the Statutes to be adopted within the first five years after the establishment of ECCSEL ERIC shall require a unanimous vote of the General Assembly. After the initial five years, such changes shall require a two-thirds majority vote. The proposed change to the Statutes must be submitted to the European Commission in accordance with Article 11 of Regulation (EC) No 723/2009.
Article 23
Winding-up
1. The General Assembly may with a two-thirds majority vote decide to wind up ECCSEL ERIC.
2. Without undue delay and in any event within 10 days after adoption of the decision to wind up ECCSEL ERIC, ECCSEL ERIC shall notify the European Commission about the decision.
3. Assets remaining after payment of ECCSEL ERIC debts shall be apportioned among the Members in proportion to their accumulated annual fee to ECCSEL ERIC as specified in Annex II.
4. Without undue delay and in any event within 10 days of the closure of the winding-up procedure, ECCSEL ERIC shall notify the European Commission thereof.
5. ECCSEL ERIC ceases to exist on the day on which the European Commission publishes the appropriate notice in the Official Journal of the European Union.
Article 24
Applicable law
ECCSEL ERIC shall be governed, by precedence:
|
a) |
by European Union law, in particular Regulation (EC) No 723/2009; |
|
b) |
by the law of the Host Country in case of a matter not covered (or only partly covered) by European Union law; |
|
c) |
by these Statutes. |
Article 25
Disputes
1. The Court of Justice of the European Union shall have jurisdiction over litigation among the Members in relation to ECCSEL ERIC, between Members and ECCSEL ERIC and over any litigation to which the European Union is a party.
2. European Union legislation on jurisdiction shall apply to disputes between ECCSEL ERIC and third parties. In cases not covered by Union legislation, the law of the Host State shall determine the competent jurisdiction for the resolution of such disputes.
Article 26
Availability of Statutes
The Statutes shall be publicly available at the ECCSEL ERIC website and at the statutory seat.
(2) OJ L 347, 11.12.2006, p. 1.
ANNEX I
LIST OF MEMBERS AND OBSERVERS
In this Annex the Members and Observers, and the entities representing them. The Annex is to be updated by the Director according to changes in the participation in ECCSEL ERIC.
Members
|
Country or Intergovernmental organisation |
Representing entity |
|
France |
The French Geological Survey (BRGM) |
|
Italy |
National Institute of Oceanography and Experimental Geophysics (OGS) |
|
Netherlands |
Netherlands Organisation for Applied Scientific Research (TNO) |
|
Norway |
|
|
UK |
British Geological Survey (BGS) |
Observers
|
Country or Intergovernmental organisation |
Representing entity |
|
|
|
ANNEX II
BUDGET CONTRIBUTIONS AND DISTRIBUTION
The founding Members and Observer of ECCSEL ERIC have agreed to this five-year budget (2016 rates). Disregarding the host-country’s contribution of 1/3 of the total cost, the Members and Observer have agreed that the expenditures shall be divided equally among them, not exceeding EUR 80 000 per Member and Observer annually in the first five years. The exact individual annual fees will depend on the number of new Members and/or Observers acceding ECCSEL ERIC.
The budget covers the ECCSEL Operations Centre, responsible for central management and planning as well as coordination of the infrastructure operations and development. At present, the founders do not have any plans implying that ECCSEL ERIC will operate or finance research facilities itself.
|
Planning Period |
2017 |
2018 |
2019 |
2020 |
2021 |
2017-2021 |
|
|
start-up year (*1) |
full operational phase |
|
|||
|
EXPENDITURES |
||||||
|
Operations Centre personnel |
235 000 |
400 000 |
500 000 |
600 000 |
600 000 |
2 335 000 |
|
IT system |
10 000 |
25 000 |
25 000 |
25 000 |
25 000 |
110 000 |
|
Office renting |
15 000 |
20 000 |
30 000 |
30 000 |
30 000 |
125 000 |
|
Travel |
25 000 |
40 000 |
50 000 |
50 000 |
50 000 |
215 000 |
|
Outsourced services |
75 000 |
115 000 |
145 000 |
145 000 |
145 000 |
625 000 |
|
Total Expenditures (EUR) |
360 000 |
600 000 |
750 000 |
850 000 |
850 000 |
3 410 000 |
|
INCOME |
||||||
|
Hosting Country (Norway) |
120 000 |
200 000 |
250 000 |
284 000 |
284 000 |
1 138 000 |
|
Member & Observer States (*2) |
240 000 |
400 000 |
500 000 |
566 000 |
566 000 |
2 272 000 |
|
Total Income (EUR) |
360 000 |
600 000 |
750 000 |
850 000 |
850 000 |
3 410 000 |
|
COSTS PER MEMBER |
||||||
|
Number of Members (excl. host) (*3) |
3 |
5 |
7 |
9 |
11 |
|
|
Costs per Member (EUR) (*4) |
80 000 |
80 000 |
71 429 |
62 889 |
51 455 |
345 772 |
(*1) First year partly overlap with implementation INFRADEV-3 HORIZON 2020 funding
(*2) The General Assembly may decide an initial Observer fee different from the normal fee.
(*3) Projected number of members and observers (excl. hosting country) - minimum scenario.
(*4) The cost will be lower with more countries joining. Foreseen support from the industry is not taken into account.
|
8.7.2017 |
EN |
Official Journal of the European Union |
C 220/29 |
ESSA hygiene guideline for the production of sprouts and seeds for sprouting
(2017/C 220/03)
Abstract
The EU sprouted seeds market is a highly specialised niche segment of the fresh produce market with approximately 120 professional production establishments throughout the EU. After the EHEC crisis in 2011 and EFSA's ‘Scientific Opinion on the risk posed by Shiga toxin-producing Escherichia coli (STEC) and other pathogenic bacteria in seeds and sprouted seeds’, new EU legislation entered into force to enhance the safety of this product segment across Europe. Different national guidelines were created to help in the implementation of these specific rules. The purpose of this European guideline, written by the European Sprouted Seeds Association (ESSA), is to give comprehensive instructions on the hygienic practices for the safe production of sprouts and seeds for sprouting, and make this information available to sprout producers in European countries and beyond.
This guideline may be used to create checklists and schemes in order to facilitate the application of the guideline.
Scope of this guide
This guideline refers to the commercial production of sprouts and seeds for sprouting in accordance with applicable legislation of the European Union. The germination of seeds — moistening seeds to increase the water content in them and bring them out of dormancy, until a new plant starts growing upward — is primary production in the EU. This hygiene guideline covers activities that are part of primary production. Activities outside the scope of primary production are not covered, but alternative guidance may be available and listed in the references below. This guideline does not cover the production of other sprouted seeds, like microgreens, shoots, cress and products that are cultivated in growing media or soil in greenhouses. Sprouted seeds commodities excluded from the scope of this guidance are covered by Commission Recommendation – Guidance document on addressing microbiological risks in fresh fruit and vegetables at primary production through good hygiene (1).
Applicable EU legislation for the production of sprouts and seeds for sprouting
The general food safety requirements including the obligation to only place safe food on the market are laid down in Regulation (EU) No 178/2002. The hygienic production of foodstuffs in the EU is covered by Regulation (EC) No 852/2004 and in particular by Annex 1 Part A of this regulation. It obliges primary producers to make sure that primary products are protected against contamination, for example by putting measures in place that prevent contamination from the air, soil, water, fertilisers, plant protection products and biocides and the storage, handling and disposal of waste. The present guidelines give practical examples to supplement these general provisions.
More specific requirements for the production of sprouts are laid down in several additional EU regulations: Commission Implementing Regulation (EU) No 208/2013 on traceability requirements for sprouts and seeds intended for the production of sprouts, Commission Regulation (EU) No 209/2013 (amending Regulation (EC) No 2073/2005) on microbiological criterion for sprouts, Commission Regulation (EU) No 210/2013 on the approval of establishments producing sprouts and Commission Regulation (EU) No 211/2013 (amended by Commission Regulation (EU) No 704/2014) on certification requirements for imports of sprouts and seeds for sprouting into the EU. The requirements of these regulations are included in this guideline.
All pieces of EU legislation mentioned throughout this guide are referenced in Annex I of this guide. Annex II provides references to other relevant sources of information related to the production of sprouts.
This guideline covers the minimum requirements for production of sprouts in the EU. Some EU Member States may have more stringent requirements for the sprout producers established in these Member States. It is generally recommended that sprout producers keep in contact with their competent authority to keep informed about the applicable rules in their relative Member State.
Additional documents going beyond the present guidelines
Additional guidance is available through relevant publications of the Codex Alimentarius, general good agricultural practices (GAP) and hygiene practices (GHP) developed by different national authorities as well as guidelines from different private stakeholders and certification schemes. Information concerning guidance documents known to the European Sprouted Seeds Association (ESSA) has been included into the references and annexes of this guideline.
DISCLAIMER
This present guideline is a recommendation without legally binding value. It has been established for information purposes only. The European Sprouted Seeds Association (ESSA) does not guarantee the accuracy of the information provided, nor does it accept responsibility for any use made thereof. Users should therefore take all necessary precautions before using this information, which they use entirely at their own risk. The duty to enforce European food safety legislation lays with the European Commission and the competent authorities of the EU Member States. Sprout producers are asked to contact their competent authority to obtain full information about the legal requirements in their Member State of establishment.
Contents
| List of abbreviations | 31 |
| DEFINITIONS | 31 |
|
1. |
SPROUTS PRODUCTION | 34 |
|
1.A. |
Establishment | 34 |
|
1.A.1. |
Approval of establishments producing sprouts | 34 |
|
1.A.2. |
Design and layout of facilities | 35 |
|
1.A.3. |
Sanitation | 36 |
|
1.A.4. |
Maintenance | 36 |
|
1.A.5. |
Worker health status | 36 |
|
1.A.6. |
Pest control | 36 |
|
1.A.7. |
Personal hygiene and suitable clothing | 37 |
|
1.A.8. |
Waste treatment | 37 |
|
1.B. |
Training | 38 |
|
1.C. |
Control of incoming seeds | 38 |
|
1.C.1. |
Import certificate | 38 |
|
1.C.2. |
Traceability requirements related to incoming seeds | 39 |
|
1.C.3. |
Visual inspection | 39 |
|
1.D. |
Seeds storage | 39 |
|
1.E. |
Hazard analysis and critical control points | 40 |
|
1.F. |
Water use | 40 |
|
1.G. |
Sprouting process | 40 |
|
1.G.1. |
Initial rinse of the seeds | 40 |
|
1.G.2. |
Microbiological decontamination of seeds | 40 |
|
1.G.3. |
Pre-germination soak | 41 |
|
1.G.4. |
Germination, growth and irrigation | 41 |
|
1.G.5. |
Harvesting | 41 |
|
1.H. |
Processing, packaging, storage and transport | 41 |
|
1.H.1. |
Final rinse, removal of hulls and cooling | 41 |
|
1.H.2. |
Microbiological decontamination of sprouts | 41 |
|
1.H.3. |
Materials and articles intended to come into contact with sprouts | 41 |
|
1.H.4. |
Storage of sprouts | 42 |
|
1.H.5. |
Product information and consumer awareness | 42 |
|
1.H.6. |
Transportation | 42 |
|
1.I. |
Microbiological testing of seeds and sprouts | 42 |
|
1.I.1. |
Guidance for sampling of seeds | 43 |
|
1.I.2. |
Sampling and testing frequency of the sprouts at least 48 hours after the start of the sprouting process | 43 |
|
1.I.3. |
Sampling of end product | 44 |
|
1.I.4. |
Test results | 44 |
|
1.I.5. |
Derogation from the preliminary testing of all batches of seeds set out in 1.I.1. | 44 |
|
1.I.6. |
Alternative testing by seed supplier | 45 |
|
1.J. |
Action in case of contamination | 45 |
|
1.J.1. |
Detection of contamination before food has left the control of the sprout producer | 45 |
|
1.J.2. |
Detection of contamination after food has left the control of the sprout producer — withdrawal and recall | 45 |
|
1.K. |
Traceability and record keeping | 46 |
|
1.K.1. |
Process traceability in the sprouting establishment | 46 |
|
1.K.2. |
Traceability requirements of final product — sprouts | 46 |
|
1.K.3. |
Exemption from the requirements in this chapter | 47 |
|
1.L. |
Summary: Recording obligation | 47 |
|
2. |
PRODUCTION OF SEEDS | 48 |
|
2.A. |
General | 48 |
|
2.B. |
Soil/land treatments | 48 |
|
2.C. |
Worker hygiene | 49 |
|
2.D. |
Irrigation | 49 |
|
2.E. |
Seeds | 49 |
|
2.F. |
Drying of plants/pods | 49 |
|
2.G. |
Threshing | 49 |
|
2.H. |
Storage after harvesting | 49 |
|
2.I. |
Processing | 49 |
| Annex I — general legislation and specific legislation on sprouts | 51 |
| Annex II — references to other relevant sources of information | 52 |
List of abbreviations
CCP: critical control point
EC: European Community
EFSA: European Food Safety Authority
ESSA: European Sprouted Seeds Association
EU: European Union
GAP: Good Agricultural Practices
GHP: Good Hygiene Practices
HACCP: Hazard Analysis and Critical Control Points
STEC: Shiga toxin-producing E.coli O157, O26, O111, O103, O145 and O104:H4
WHO: World Health Organisation
DEFINITIONS
Batch (2) : a quantity of sprouts or seeds for sprouting with the same taxonomic name, which is dispatched from the same establishment to the same destination on the same day. One or more batches can make up a consignment. However, seeds with a different taxonomic name, which are mixed in the same packaging and intended to be germinated together and sprouts thereof are also considered as one batch.
Clean water (3) : means clean seawater and fresh water of a similar quality.
Competent authority (4) : the central authority of a Member State competent for the organisation of official controls or any other authority to which that competence has been conferred; this can also, where appropriate, refer to the corresponding authority of a third country.
Consignment (5) : a quantity of sprouts or seeds intended for the production of sprouts and which is: (i) originating from the same third country; (ii) covered by the same certificate(s); (iii) conveyed by the same means of transport.
Contamination (6) : means the presence or introduction of a hazard.
Cress (7) : sprouted seeds obtained from the germination and development of true seeds in soil or in hydroponic substrate, to produce a green shoot with very young leaves and/or cotyledons. Cress is sold as the entire plants in its substrate or soil.
Critical control point (CCP) (8) : a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.
Establishment (9) : means any unit of a food business.
Good agricultural practices (GAP) (10) : practices that address environmental, economic and social sustainability for on-farm processes, and result in safe and quality food and non-food agricultural products.
Good Hygiene Practices (GHP) (11) : general, basic conditions for hygienic production of a foodstuff, including requirements for hygienic design, construction and operation of the establishment, hygienic construction and use of equipment, scheduled maintenance and cleaning, and personnel training and hygiene. A developed and implemented GHP programme is a pre-requisite for HACCP system.
Food (12) : means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans.
Food business operator (13) : means the natural or legal persons responsible for ensuring that the requirements of food law are met within the food business under their control.
Food hygiene (14) : hereinafter called ‘hygiene’, means the measures and conditions necessary to control hazards and to ensure fitness for human consumption of a foodstuff taking into account its intended use.
Food law (15) : means the laws, regulations and administrative provisions governing food in general, and food safety in particular, whether at Community or national level; it covers any stage of production, processing and distribution of food, and also of feed produced for, or fed to, food-producing animals.
Hazard (16) : means a biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect.
Hazard analysis (17) : the process of collecting and evaluating information on hazards and conditions leading to their presence to decide which are significant for food safety and therefore should be addressed in the HACCP plan.
Hazard analysis and critical control points (HACCP) (18) : a system which identifies, evaluates, and controls hazards which are significant for food safety.
Labelling (19) : means any word, particulars, trademarks, brand name, pictorial matter or symbol relating to a food and placed on any packaging, document, notice, label, ring or collar accompanying or referring to such food.
Microbiological criterion (20) : means a criterion defining the acceptability of a product, a batch of foodstuffs or a process, based on the absence, presence or number of micro-organisms, and/or on the quantity of their toxins/metabolites, per unit(s) of mass, volume, area or batch.
Monitor (21) : the act of conducting a planned sequence of observations or measurements of control parameters to assess whether a CCP (critical control point) is under control.
Official controls (22) : means any form of control that the competent authority or the Community performs for the verification of compliance with feed and food law, animal health and animal welfare rules.
Packaging (23) : means the placing of one or more wrapped food-stuff in a second container, and the latter container itself.
Primary production (24) : production, rearing or growing of primary products including harvesting, milking and farmed animal production prior to slaughter. It also includes hunting and fishing and the harvesting of wild products.
Primary products (25) : products of primary production including products of the soil, of stock farming, of hunting and fishing.
Potable water (26) : water meeting the minimum requirements laid down in Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption.
Ready-to-eat-food (27) : means food intended by the producer or the manufacturer for direct human consumption without the need for cooking or other processing effective to eliminate or reduce to an acceptable level micro-organisms of concern.
Representative sample (28) : means a sample in which the characteristics of the batch from which it is drawn are maintained. This is in particular the case of a simple random sample where each of the items or increments of the batch has been given the same probability of entering the sample.
Risk (29) : means a function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard.
Risk analysis (30) : means a process consisting of three interconnected components: risk assessment, risk management and risk communication.
Sample (31) : means a set composed of one or several units or a portion of matter selected by different means in a population or in an important quantity of matter, which is intended to provide information on a given characteristic of the studied population or matter and to provide a basis for a decision concerning the population or matter in question or concerning the process which has produced it.
Seeds for sprouting (32) : seeds intended for the production of sprouts.
Seed producer (33) : any person responsible for the management of activities associated with the primary production of seeds including post-harvest practices.
Seed distributor (34) : any person responsible for the distribution of seeds (handling, storage and transportation) to sprout producers. Seed distributors may deal with single or multiple seed producers and can be producers themselves.
Shoots (35) : sprouted seeds obtained from the germination and the development of seeds to produce a green shoot with very young leaves and/or cotyledons. The shoots and the leaves are harvested at the end of the production process and the final product does not include the seed integuments and the roots.
Spent sprout irrigation water (36) : water that has been in contact with sprouts during the sprouting process.
Sprouts (37) : means the product obtained from the germination of seeds and their development in water or another medium, harvested before the development of true leaves and which is intended to be eaten whole, including the seed.
Sprouted seed (38) : include the following categories: sprouts, cresses and shoots.
Sprout producer (39) : any person responsible for the management of the activities associated with the production of sprouted seeds.
Sprouted seeds distributor (40) : any person responsible for the distribution of sprouted seeds (handling, storage and transportation) to the buyer/customer. Sprouted seed distributors may deal with single or multiple sprouted seeds producers and can be producers themselves.
Substances (41) : means chemical elements and their compounds, as they occur naturally or by manufacture, including any impurity resulting from the manufacturing process.
Traceability (42) : means the ability to trace and follow a food, feed, food-producing animal or substance intended to be, or expected to be incorporated into a food and feed, through all stages of production, processing and distribution.
1. SPROUTS PRODUCTION
1.A. Establishment
1.A.1. Approval of establishments producing sprouts
Before starting production of sprouts, producers must register with the national authorities. It is a legal requirement in the EU under Regulation (EC) No 852/2004, Article 6 that all food business operators are registered by the national competent authorities. In addition, establishments located in an EU member country producing sprouts must be approved by their competent authority in accordance with Commission Regulation (EU) No 210/2013. In order to approve a sprout producer, the competent authority must verify that the operator complies with Annex I of Regulation (EC) No 852/2004 on the hygiene of foodstuffs and with the Annex of Commission Regulation (EU) No 210/2013. Sprout producers must ensure the sprouts that they produce are protected against contamination.
Sprout producers also must take measures to control contamination arising from the air, soil, water, fertilisers, plant protection products and biocides and the storage, handling and disposal of waste.
In practice, competent authorities may refer to this present guideline or the list of national guidelines to check whether sprout producers fulfil the provisions contained in Annex I of Regulation (EC) No 852/2004 on general rules on the hygiene of foodstuffs.
1.A.2. Design and layout of facilities
The legal requirements for the approval of establishments producing sprouts are listed in the annex of Commission Regulation (EU) No 210/2013. Requirements listed in Commission Regulation (EU) No 210/2013 are as follows:
|
1. |
The design and layout of establishments shall permit good food hygiene practices, including protection against contamination between and during operations. In particular, surfaces (including surfaces of equipment) in areas where foods are handled and those in contact with food shall be maintained in a sound condition and be easy to clean and, where necessary, to disinfect. |
|
2. |
Adequate facilities shall be provided for the cleaning, disinfecting and storage of working utensils and equipment. These facilities shall be easy to clean and have an adequate supply of hot and cold water. |
|
3. |
Adequate provision shall be made, where necessary, for washing food. Every sink or other such facility provided for the washing of food shall have an adequate supply of potable water and be kept clean and, where necessary, disinfected. |
|
4. |
All equipment with which seeds and sprouts come into contact shall be so constructed, be of such materials and be kept in such good order, repair and condition as to minimise any risk of contamination, and to enable it to be kept clean and, where necessary, to be disinfected. |
|
5. |
Appropriate procedures shall be in place to ensure that:
|
In addition, the following requirements should also be followed:
|
— |
sprout production should take place indoors in fully-closed buildings; |
|
— |
facilities should be designed in such a way that seeds and sprouts are kept at a distance from objects and substances that could pose a threat of contamination. The production process and other related processes (waste management, worker sanitation etc.) should be designed in such a way that any danger of cross-contamination is minimised. Where possible, there should be physical separation between the areas where seeds are received and stored, the areas where seeds are prepared and rinsed, the areas where germination takes place and the areas where sprouts are cooled and packaged. Where possible, seeds and sprouts should not return into a room in which they have already been. Where appropriate, the flow of the production process could be indicated to staff through signs or labels. Facilities should be easy to clean and to maintain; |
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sanitary facilities should be equipped with running clean hot water, soap dispensers and hand drying equipment (e.g. disposable towels). Preferably automatic sensor taps should be installed. Wherever possible, they should be constructed in such a way that they do not provide direct access to the area in which the production process takes place. Sanitary facilities should be equipped to ensure hygienic removal of waste and undergo regular cleaning and maintenance as appropriate; |
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a cloakroom or equivalent should be available for workers (see point 1.A.7.); |
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to prevent contamination from air, due care should be taken that food products are not directly exposed to air from origins that may be contaminated (e.g. mould, moisture etc.). Air conditioning should not blow directly onto food products. Where appropriate and feasible, instruments to de-oil, dehydrate and filter the air should be used. Where necessary, these instruments should undergo regular maintenance. |
Some EU Member States may have more stringent requirements for the design and layout of facilities.
1.A.3. Sanitation
Where appropriate, sanitation work should be done by cleaning and disinfection of surfaces and equipment. Sprouting facilities should have a written cleaning plan (indicating methods and schedule of personnel) to ensure that all relevant areas of the facility will be regularly cleaned. The cleaning plan should mention the frequency at which cleaning takes place. This plan should identify areas where moisture, mould, dirt, animals, insects or bacteria are likely to establish themselves, and describes how to prevent this from happening.
All equipment that comes into contact with seeds or sprouts should be regularly cleaned and disinfected followed by final rinsing with water in accordance with the instructions of the cleaning products if required. Only approved cleaning products should be used and only potable water or water of a trusted source can be used for cleaning and disinfection. Where possible, equipment should be easy to clean or disinfect.
Cleaning and disinfection should be carried out in a way that makes it impossible for food products to be contaminated with cleaning products (e.g. by cleaning at times when no seeds are sprouted). If biocidal products are used then these biocides must meet requirements listed in European regulation on biocides (Delegated Regulation (EU) No 1062/2014) and provisions set by national authorities.
Sufficient time should be given in accordance with the instructions of the cleaning product before cleaned/disinfected surfaces come into contact with food products again.
Sprouting companies should keep records of the dates of cleaning and disinfection and the areas and pieces of equipment that have been cleaned and chemical used.
Any danger of contamination from glass or metal shards, debris, chemical substances, cleaning and disinfection products or other dangerous objects should be minimised by keeping these objects separate from the production process. Cleaning and disinfection products should be stored in a dedicated location or closet that is kept locked and carries appropriate signs or labels.
1.A.4. Maintenance
Where maintenance work is conducted, this should be done in such a way that contamination of food products is impossible (e.g. by conducting repair work outside of the production area or at times when no production is taking place). Where appropriate, maintenance work should be followed by cleaning or disinfection of surfaces and equipment that will come into contact with food products.
Records of the maintenance work including dates and identification of the objects that are covered should be kept.
1.A.5. Worker health status
Staff members known or suspected to have a disease or illness that can be transmitted to the sprouts should not be allowed into areas where they may come into direct or indirect contact with seeds or sprouts.
Staff injuries that could present a danger of contamination should be adequately treated with waterproof detectable covers before the worker can come into contact with seeds or sprouts. Where possible, wounded workers should avoid direct contact with seeds or sprouts for human consumption.
1.A.6. Pest control
The production facility should be kept in a general good condition that makes it difficult for pests or animals to access the facility or establish themselves inside.
Access of pests and animals should be prevented by keeping windows and other entry paths closed and by protecting windows with mesh wire or other materials where appropriate. Other outlets that could allow the access of pests or animals should be kept sealed. Infrastructure related to the production process (e.g. pipes or air ducts) should be constructed or fitted in a way to prevent access of pests or contaminating substances.
For prevention reasons, in order to prevent any possible establishment of pests in the facilities, the operators should set a pest control plan and provide pest traps. A contract with pest control firm should be set up.
1.A.7. Personal hygiene and suitable clothing
In a general manner, staff members should keep a high degree of personal hygiene.
Everyone who works in a food preparation area must practice good personal hygiene. All workers should be aware of the principles of hygiene and health, and should be informed about all the dangers that could contaminate the product. They should receive hygiene training appropriate to their tasks and be periodically assessed. Such training should be delivered in a language and manner to ensure understanding of the required hygienic practices.
Staff and visitors should wear clean clothing and wear head covering while they are in the production facility.
Overall, the entering of visitors into processing or storage areas should be forbidden unless they have been informed about hygiene requirements. Visitors who enter these areas should be provided with a suitable uniform and their names should be recorded. Records should be kept for an appropriate amount of time.
Staff working in food handling areas must practice good hygiene:
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have clean hands or wear gloves if they are handling seeds and sprouts; |
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not smoke or spit in the food handling area; |
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avoid contamination of sprouts through sneezing and coughing over them; |
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ensure that hair does not pose a risk of contamination; |
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cover cuts, wounds, healing skin or other skin conditions likely to cause contamination of foods (on hands or other exposed parts of the body) with waterproof dressings; |
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not wear jewellery or beauty products that may present a risk of contamination; |
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staff should keep their fingernails short and clean. |
Hands should be washed:
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before handling ready-to-eat food; |
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after a break; |
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after going to the toilet; |
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after cleaning; |
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after removing waste. |
Although there may be slight variations on hand washing techniques all include the following steps:
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wetting of hands before applying soap; |
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thorough hand rubbing, to remove contamination from all parts of the hands; |
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rinsing of hands with potable water or water from a trusted source; |
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hygienic drying. |
Staff hygiene rules should be printed and attached to the walls either in written form or in form of signs or labels.
1.A.8. Waste treatment
Waste should be removed promptly from the vicinity of food products.
If appropriate waste bins in the production area should be covered and kept at a distance from food products and emptied on a daily basis. Large amounts of waste should be immediately removed from the production area.
Where larger waste containers are necessary, these should be kept outside the production area, where possible in an area that is inaccessible to rodents, animals, insects and other pests.
Waste bins and containers should be regularly cleaned and regularly disinfected.
1.B. Training
All staff coming into direct or indirect contact with seeds or sprouts must receive training in order to obtain a proper understanding of:
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implementation and supervision of a food safety management system; |
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food safety procedures; |
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food allergen management; |
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food hazards and the risks associated with them; |
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risks linked to cross contamination; |
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importance of high standards of cleanliness in the production, handling and packaging areas; |
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techniques involved in controlling and monitoring food safety; |
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personal hygiene and suitable clothing (see point 1.A.7.). |
All personnel involved in sanitation should receive training to understand the cleaning and disinfection plan, the handling of chemical substances and the separation of cleaning products from the production process.
Sprout producers should keep records of the dates of training, the topics that have been covered and the participating employees.
1.C. Control of incoming seeds
Food producers are under obligation of the EU's general food law regulation (Regulation (EC) No 178/2002) to only put safe products on the market. This means that sprout producers will be held responsible for any contamination that may have occurred in earlier stages of the supply chain before the arrival of the seed batches in the sprouting facility. For this reason, sprout producers should only purchase seeds from trusted suppliers that have procedures in place to assure good hygienic production of the seeds and traceability of the batches.
Sprout producers should only purchase seed that has been grown in such a way that the risk of contamination with pathogens is minimised (seeds should be fit for purpose).
This chapter and the provisions on seed production contained in the second chapter of this guideline provides help to meet this requirement.
1.C.1. Import certificate
If the seeds for the purpose of sprouting are originating from non-EU countries, it is obligatory that each consignment of seeds is accompanied by an import certificate during all stages of trade as required by Commission Regulation (EU) No 704/2014 (amendment of Commission Regulation (EU) No 211/2013). A copy of this certificate must be made available to the sprout producer and kept on record by the sprout producer for a sufficient time after the sprouts can be assumed to have been consumed. The certificate must be issued in the official language or languages of the issuing country and the language or languages of the country of reception. Where this is not possible, the certificate can also be accompanied by a certified translation into the language of the country of reception. Where seeds arrive in one EU Member State and are then sent to another EU Member State, the competent authority of the receiving country may request certified translations of the certificate into its own language. A specimen of the import certificate can be found in Commission Regulation (EU) No 211/2013.
If sprout producers sell batches of seeds to a different sprout producer with the intention to be sprouted in that establishment, every batch of seeds must be accompanied by a copy of the corresponding import certificate and a document with the traceability information given above, including the name and address of the seed supplier and the sprout producer who initially received the seeds. If information on the supplier of seeds for sprouting for commercial reasons is hidden in the copy of import certificate, such information should be disclosed to the buyer and competent authorities in case of contamination of seeds. If traders are involved in the supply chain of seeds for sprouting, these must also follow the same traceability requirements.
If a batch of seeds originating from a non-EU country is not accompanied by this certificate, it must not be used to produce sprouts for human consumption.
The import certificate needs to be issued by the competent authority of the exporting country (normally the health or food safety authority or Agriculture ministry). By signing the certificate, the competent authority certifies that the seeds were grown in compliance with the requirements in Annex 1 Part A of Regulation (EU) No 852/2004 (i.e. good hygiene practices). The second part of this guideline (see Chapter 2. Production of seeds) contains practical examples that supplement the general requirements in Regulation (EU) No 852/2004. Chapter 2 of this guideline can therefore give valuable support to authorities in third countries and also within the EU to determine whether the general requirements in Annex 1 Part A of Regulation (EU) No 852/2004 for seed production are fulfilled or not.
Where a batch of seeds for sprouting is packaged and sold to retail with the intention to be sprouted by the final consumer, the batch must also be accompanied by a copy of the import certificate. The copies of the certificate shall be provided to business operators to which the seeds are dispatched until they are packed for sale at retail.
1.C.2. Traceability requirements related to incoming seeds
Sprout producers must obtain a document with the following information from their seed suppliers – regardless whether EU or non-EU supplier – for each batch of seeds (a consignment can consist of several batches):
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name of the product including the Latin name (taxonomic name); |
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identification number or equivalent batch reference; |
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name of the supplier; |
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name and address of the recipient (if a forwarder or agent is used: name and address of the agent or forwarder); |
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date of shipping; |
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quantity supplied. |
The seed suppliers should keep a copy of this document on record.
Seed suppliers and earlier stages in the supply chain are required to keep additional information on record as stipulated in Commission Implementing Regulation (EU) No 208/2013.
The seed suppliers and the sprout producers must keep a copy of this document on record for a sufficient time after the sprouts can be assumed to have been consumed.
If seeds have been procured from a supplier outside of the European Union, the batch of seeds must be accompanied by an import certificate and record of the certificate should be kept. Rules with regards to import certificate are listed in point 1.C.1.
Sprout producers should put in place a system to ensure traceability of the batches from the moment of arrival of the seeds until the moment of dispatch of the sprouts. Records should be kept for a sufficient time after the sprouts can be assumed to have been consumed. Traceability requirements of the final product – sprouts are listed in point 1.K.
1.C.3. Visual inspection
Bags/containers and seeds should be visually checked (e.g. for physical contamination with human or animal waste, unpatched holes in bags which obviously do not come from sampling probes, stains, foreign matter etc.) after arrival or prior to sprouting. Documents should be available attesting that the visual inspection has taken place.
1.D. Seeds storage
Seeds should be stored in new sound bags without holes (except patched holes or equivalent that come from sampling probes or other procedural elements), and not in used or second hand bags to avoid chemical or microbiological contamination. Bags should be kept dry. Where possible, bags should not be stored on the floor and not immediately against walls but on pallets and with clean cardboard sheets between the bags and the pallet. Producers should also consider whether it is necessary to cover the tops of storage piles with suitable material to protect the goods.
Storage areas and equipment should be cleaned and kept dry. Measures should be in place to prevent ingress and contamination from weather, animals and pests (see point 1.A.2).
Where sprout producers handle seeds intended for the production of sprouts as well as seeds not destined for sprout production, these should be kept clearly separated, and where appropriate, clearly labelled to avoid any mixing. Due care should be taken to ensure that stored batches correspond to the records and that these batches will be traced throughout the production process.
1.E. Hazard analysis and critical control points
The sprouting of seeds involves minimal processing of the original product and can therefore be considered primary production. The application of hazard analysis and critical control points (HACCP) principles to primary production is currently not legally required by European legislation (Regulation (EC) No 852/2004), but is considered essential by ESSA.
‘Commission Notice on the implementation of food safety management systems covering prerequisite programs (PRPs) and procedures based on the HACCP principles, including the facilitation/flexibility of the implementation in certain food businesses’ (43) provides guidance on how to implement good hygiene practices and HACCP-based procedures.
1.F. Water use
During all steps of the production process, water that comes into contact with seeds or sprouts should be water meeting the microbiological requirements of potable water listed in Council Directive 98/83/EC, part A.
If clean water (which meets microbiological requirements listed in Council Directive 98/83/EC, Part A) is used, then the chemical properties of the water from that source should be analysed based on the risk assessment, but at least once a year.
Water delivery systems should be appropriately maintained and cleaned (see point 1.A.3. and point 1.A.4.) to avoid contamination of the water from corrosion or external sources. Records of the maintenance should be kept.
A water recycling system may only be used during germination, growth and irrigation processes. If water is recycled, it is recommended to reuse the water within the same batch of seeds/sprouts and not spread over multiple batches in order prevent the contamination of the whole ongoing production, instead of production in one batch.
Any water, including recycled water should be monitored and analysed regularly based upon a risk analysis (according to Council Directive 98/83/EC, part A).
Measures should be taken to prevent the access of insects, animals, soil, waste and other sources of contamination to the water source.
If water is treated with biocidal products in order to meet microbiological parameters set in Council Directive 98/83/EC, part A, then these treatments must meet requirements listed in European regulation on biocides (Delegated Regulation (EU) No 1062/2014) and provisions set by national authorities.
1.G. Sprouting process
1.G.1. Initial rinse of the seeds
Depending on the results of the visual inspection, seeds should be rinsed thoroughly before sprouting to remove dirt. Agitating seeds thoroughly in the washing container can improve the removal of dirt.
Potable water or clean water which meets microbiological requirements listed in Council Directive 98/83/EC, Part A, must be used for the rinsing of seeds. The water used for the washing of seeds should not be reused.
1.G.2. Microbiological decontamination of seeds
There is no harmonization within the European Union in terms of using microbiological decontamination treatments on seeds. However, only treatments authorised by national competent authorities are allowed for microbiological decontamination of seeds.
According to EFSA-report ‘Scientific Opinion on the risk posed by Shiga toxin-producing Escherichia coli (STEC) and other pathogenic bacteria in seeds and sprouted seeds’ (44) there is limited information on the efficacy of decontamination treatments of sprouts derived from seeds. Despite considerable efforts, to date, no chemical, physical or biological methods of disinfection have been able to ensure the seed to be pathogen free. Decontamination treatments should not kill seed or reduce the germination rate.
If microbiological decontamination is used, there should be measures in place to ensure that re-contamination cannot take place once the seeds have been decontaminated. Due care should be taken that containers and equipment used for decontamination have been disinfected. Following decontamination, seeds should be rinsed with potable water once again to eliminate chemical agents.
1.G.3. Pre-germination soak
Where sprout producers make use of pre-germination soaking, this should be done in potable water or clean water, which meets microbiological requirements listed in Council Directive 98/83/EC, Part A. Equipment and containers used for soaking should be thoroughly cleaned, disinfected and rinsed before use and should be suitable for food production. The water used for soaking should not be directly reused.
1.G.4. Germination, growth and irrigation
The germination chamber should be kept in good hygienic conditions. The chamber itself and equipment used during the germination process should be cleaned and disinfected before sprouting a new batch of seeds.
It is strictly required to use potable water or clean water which meets microbiological requirements listed in Council Directive 98/83/EC, Part A, as initial source of irrigation water during the sprouting process to prevent contamination and potential outgrowth of pathogens during the sprouting process.
If recycled water is used, it should meet requirements listed in point 1.F. on water use.
1.G.5. Harvesting
Only equipment suitable for food production should be used for harvesting of sprouts. All equipment used should be cleaned and disinfected at least on a daily basis. Workers should take due care that they and their uniform or clothes are in good hygienic conditions before entering the germination chamber.
1.H. Processing, packaging, storage and transport
1.H.1. Final rinse, removal of hulls and cooling
Equipment used for rinsing of sprouts and removal of hulls should be cleaned and disinfected at least on a daily basis.
For the final rinse, removal of hulls and cooling only potable water or clean water that meets microbiological requirements listed in Council Directive 98/83/EC, Part A, should be used. After rinsing and removal of hulls, sprouts should be immediately refrigerated at the temperature between 2 – 8 °C. In following, the cold chain should be upheld until the product reaches the final consumer. For the entire period of the cold chain (cold room, truck, etc.), the temperature of the cold chain should be monitored. Different national cold chain requirements may apply.
1.H.2. Microbiological decontamination of sprouts
There is no harmonization within the European Union in terms of using microbiological decontamination treatments on sprouts. However, only treatments authorised by competent authorities are allowed for microbiological decontamination of sprouts.
The same conditions as listed in point 1.G.2. on microbiological decontamination of seeds apply.
1.H.3. Materials and articles intended to come into contact with sprouts
During production process, various materials come into contact with sprouts. Any materials and articles intended to come into contact with food which is placed on the market should comply with the requirements of the Regulation (EC) No 1935/2004.
Due care should be taken that packaging material is clean and stored in a way that makes contamination with dust, dirt or foreign matter impossible.
Packing should take place indoors in closed and dry areas that prevent the ingress of dust, dirt or other sources of contamination.
Equipment used for packing should be regularly cleaned and disinfected (see point 1.A.3).
1.H.4. Storage of sprouts
Care should be taken that sprouts are stored in closed and protected environments that prevent the access of dust, dirt or other sources of contamination. Storage areas should be equipped in such a way that the cold chain for sprouts can be upheld (see point 1.H.1.).
1.H.5. Product information and consumer awareness
The customer or next person in the supply chain should be supplied with all the information relevant to them to handle, store, process, prepare and display the product safely and correctly. Where appropriate and useful, this information can be included into the packaging label.
Products should be correctly labelled to facilitate traceability and recall where necessary (see points 1.J. and 1.K.). Identification or batch numbers as well as name and address of the producer on the packaging label may facilitate traceability and recall.
All legal labelling requirements set in Regulation (EU) No 1169/2011 should be fulfilled and all mandatory information which is required in this regulation should be provided on the label.
Labelling, advertising, consumer information material and packaging should not mislead the consumer.
1.H.6. Transportation
Facilities, equipment, containers, crates, vehicles and vessels used to transport sprouts and seeds should be kept clean and where possible disinfected in order to prevent from microbiological contamination during transport.
Transport time is a part of the total shelf life of the sprouts and must therefore be seen as an integrated part of the cold chain (see point 1.H.1.).
1.I. Microbiological testing of seeds and sprouts
According to Commission Regulation (EC) No 2073/2005, amended by Commission Regulation (EU) No 209/2013, sprout producers must carry out a preliminary testing of a representative sample of each batch of seeds. This testing is obligatory for Shiga toxin producing E.coli (STEC) O157, O26, O111, O103, O145 and O104:H4 and Salmonella spp. with the objective of this test is to use only positive released batches of seeds (see point 1.I.1.).
Sprout producers should carry out testing of the sprouts for Shiga toxin producing E.coli (STEC) O157, O26, O111, O103, O145 and O104:H4 and Salmonella spp. at the stage where the probability of finding these pathogens is the highest, in any case not before 48 hours after the start of sprouting process at least once a month. There is no obligation to test each batch of the sprouted seeds as the objective is to verify the currently implemented good practices and food safety management system (see point 1.I.2.).
Commission Regulation (EC) No 2073/2005 also obliges producers to test sprouts on food safety criteria when products are placed on the market during the shelf-life period. Tested sprouts should meet limits set in category 1.18 for Salmonella spp. and in category 1.29 for STEC. Moreover, ready-to-eat products like sprouts also are required to be tested for Listeria monocytogenes. These tests do not need to be done for every batch, but it should be done at regular intervals and it is also used as a verification of good practices. The frequency of testing for STEC, Salmonella spp. and L. monocytogenes should be fixed by the operator – if possible after consultation with the competent authority – and be risk based. To analyse sprouts for L. monocytogenes, criterion 1.3 of Annex I of Commission Regulation (EC) No 2073/2005 must be applied.
Sprout producers are also recommended to sample the processing areas and equipment for Listeria spp. as part of their sampling scheme.
1.I.1. Guidance for sampling of seeds
These samples should be treated according to Chapter 3.3 in Commission Regulation (EC) No 2073/2005 and analysed according to the requirements in rows 1.18 and 1.29 of Chapter 1 of the same regulation. For each batch of seeds to be sprouted a preliminary testing should be performed. For the purpose of performing the preliminary testing, the food business operator must sprout the seeds in the representative sample under the same conditions as the rest of the batch of seeds to be sprouted. A representative sample shall include at least 0,5 % of the weight of the batch of seeds in sub samples of 50 g. The representative sample can also be selected based on a structured statistically equivalent sampling strategy, if this has been verified by the competent authority. In principle, each bag in the batch should be sampled and the number of sub samples per bag is decided according to the following calculation:
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the total weight of the sample = the total weight of the batch * 0,5 % (= 0,005) |
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the total number of sub samples = the total weight of the sample/50 g |
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the number of bags in the batch = the total weight of the batch/the weight of each bag |
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the number of 50g sub samples per bag = the total number of sub samples/the number of bags in the batch |
For example, to sample a batch of 100 tons, packed in 25 kg bags:
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the total weight of the sample = 100 000 kg * 0,5 % = 500 kg |
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the total number of sub samples = 500 kg/50 g = 10 000 sub samples |
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the number of bags in the batch = 100 000 kg/25 kg per bag = 4 000 bags |
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the number of 50 g sub samples per bag = 10 000 sub samples/4 000 bags = 2,5 sub samples/bag |
Due care should be taken that this is carried out in hygienic conditions and with equipment that is in good hygienic condition. Appropriate records of the sampling process should be kept to prove correct sampling vis-à-vis the competent authority.
The sampling should be carried out by food business operators producing sprouts and can be done manually or mechanically by sprouts grower or by an accredited third party. Some companies will use mechanical sampling devices that extract representative quantities of seeds e.g. while refilling bulk deliveries into smaller bags, subject to confirmation by the competent authorities. Other companies will pierce and reseal bags or equivalent to extract the representative quantity of seeds.
It is the responsibility of sprout producer to make sure that the sample is representative and the testing is done according to the rules set in Commission Regulation (EU) No 209/2013.
As long as the sampling requirements are fulfilled, it should be possible for sprout producers to ask seed suppliers to conduct sampling at origin at the moment of packing the bags, and to send the sample to the sprout producer along with the batch, in (a) separate and clearly labelled bag(s) (labelled ‘sample for microbiological testing’ or equivalent).
In case sampling of seeds is done by third party, then mechanical sampling devices at origin should be preferably an integral part in the process of packing the bags. In case the sprout grower does not carry out the sampling of seeds himself, he should verify that sampling is carried out according to Commission Regulation (EU) No 209/2013
The sprouting process for the other seeds in the representative test sample may continue as usual. However, both the sprouts growing out of the remaining culture after sampling as well as the remaining dry seeds from which the sample was taken should not be used unless satisfactory results for all of the samples have been reported by the laboratory. This is the principle of positive batch release.
1.I.2. Sampling and testing frequency of the sprouts at least 48 hours after the start of the sprouting process
Five samples should be taken at the stage where the probability of finding Shiga toxin producing E.coli (STEC) O157, O26, O111, O103, O145 and O104:H4 and Salmonella spp. is the highest, in any case not before 48 hours after the start of the sprouting process, at least once a month to verify the good practices and food safety management. No systematic sampling of batches is required.
The five samples should be kept separate from each other and be sent to a laboratory accredited (ISO 17025) for the testing of STEC and Salmonella spp.
These samples should be treated according to Chapter 3.3 in Commission Regulation (EC) No 2073/2005 and analysed according to the requirements in rows 1.18 and 1.29 of Chapter 1 of the same regulation.
Or, if the sprout producer has a sampling plan, including sampling procedures and sampling points of the spent sprout irrigation water, the competent authority may authorise them to replace the sampling requirement of the sprout with minimal age of 48 hours under the sampling plans set out in rows 1.18 and 1.29 of Chapter 1 in Commission Regulation (EC) No 2073/2005 with the analysis of 5 samples of 200 ml of the water that was used for the irrigation of the sprouts. This method provides more representative sample of the seeds to be tested. This is the reason that ESSA strongly recommends to analyse the spent irrigation water that has been in contact with 100 % of the sprouts of the test batch. The testing method when five samples of 25 grams of sprouts from the batch are analysed is much less reliable and accurate.
1.I.3. Sampling of end product
In addition, sprouts, being the packed end product, should also be sampled (with n = 5) and analysed for STEC and Salmonella spp. according to row 1.18 and 1.29 of Commission Regulation (EC) No 2073/2005 (see point 1.I.2.). The analysis should be carried out after the packing of product. The sampling frequency should be defined on a basis of risk.
A challenge test should point out how to analyse L. monocytogenes, i.e. according to row 1.2 or 1.3 in Chapter 1 of Annex 1 Commission Regulation (EC) No 2073/2005 (see also 1.I.). Analysis should be carried out according to the result of this evaluation.
1.I.4. Test results
None of the five samples (representative samples or samples of end product) may show positive findings for STEC or Salmonella spp. If the absence of microbiological contamination has been proven by the laboratory, sprouts produced from the analysed batch may be placed on the market.
Actions in case of contamination of seeds or food/sprouts are listed in point 1.J.1.
In case of sprouts are contaminated with L. monocytogenes, these sprouts may be submitted for further processing, however a treatment eliminating the hazard should be applied. This can also be applied for STEC or Salmonella spp. as long as the treatment eliminates the risk and is approved by the competent authority. This treatment may only be carried out by food business operators other than those at retail level (Commission Regulation (EC) No 2073/2005).
1.I.5. Derogation from the preliminary testing of all batches of seeds set out in 1.I.1.
Under Chapter 3, section 3.3.B. of Annex I of Commission Regulation (EC) No 2073/2005 (as amended by Commission Regulation (EU) No 209/2013) competent authorities can exempt sprout producers from the obligation to test every single batch of seeds, if the sprouting facility implements a food safety management system with steps that reduce the microbiological risk. However, this exemption can only be granted under certain conditions determined by the competent authority and if historical data is available to confirm that all batches of the six consecutive months before authorisation did not result in any findings of STEC and Salmonella spp. In this case, sprout producers must keep all their testing results on record for more than six months.
The European Sprouted Seeds Association (ESSA) cautions sprout producers to carefully weigh the balance between the high cost of analysis and the potentially disastrous consequences of a food safety problem which may result from only one single contaminated batch of seeds. Where seeds are sourced from new origins, it is therefore highly recommended to conduct testing even if a derogation has been granted to the sprout producer and even if the seeds are delivered by the same trader or supplier. Where sprout producers have reason to doubt the integrity of the product, it is also highly recommended to conduct an analysis as a precautionary measure. As a conclusion, ESSA is not an advocate of this derogation because of the fact that different years of harvest of seeds most probably will result in different contamination risks of the seeds.
The exemption in Chapter 3 Section 3.3.B. of Annex I of Commission Regulation (EC) No 2073/2005 does not relieve sprout producers from the duty to sample the sprouts or the sprout irrigation water at the stage of the final product at least once every month. It is however provided in footnote 23 in Annex I of Commission Regulation (EC) No 2073/2005 that sprouts which have received a treatment effective to eliminate Salmonella spp. and STEC (if approved by the competent authority) do not need to undergo the monthly testing obligation.
1.I.6. Alternative testing by seed supplier
It is within the discretion of the sprout producer to ask their seed supplier for preliminary testing of the batch. However, this does not exempt the sprout producer from the testing obligations detailed in this chapter.
1.J. Action in case of contamination
1.J.1. Detection of contamination before food has left the control of the sprout producer
The contaminated batch of sprouts or seeds should immediately be isolated from all others. The entire batch should be considered unsafe to eat/sprouting. If there is a danger that other batches may be contaminated, the production process should be interrupted until a point where the contamination has been eliminated and the production line is in a clean and hygienic state.
Sprouts or seeds from the contaminated batch or batches should not be placed on the market for human consumption in their current state. However, contaminated sprouts may be submitted to further processing by a treatment eliminating the hazard in question. This treatment may only be carried out by food business operators other than those at retail level.
As an example, if mung beans are contaminated, it is possible to manufacture to split mung beans, which will not germinate and will not produce any sprout. With the appropriate precautions, that product could be sold for ‘cooking’ (including for human consumption).
More generally, the sprout producer may also use the batch for purposes other than those for which it was originally intended, provided that this use does not pose a risk for public or animal health and provided that this use has been decided within the procedures based on HACCP principles and good hygiene practice and authorised by the competent authority.
It is recommended that sprout producers lay down written procedures to follow in cases where contamination occurs. These rules should be easily accessible for all employees and covered in training programmes for staff members.
The seed supplier should be contacted so that he/she can follow up possible shipments of the same seed batch seeds to other sprout producers. In this case, recall of the seeds may be necessary.
Sprout producers should take measures and increase monitoring to find the cause of the contamination (the water, the environment, the staff, etc.). Sprout producers should keep the testing results on record for sufficient time after the sprouts can be assumed to have been consumed. It is recommended to keep all testing results on record for sufficient time so that they can be shown to competent authorities during official controls.
1.J.2. Detection of contamination after food has left the control of the sprout producer — withdrawal and recall
Articles 18 and 19 of Regulation (EU) No 178/2002 require all food business operators to have traceability and recall systems in place. Due care should be taken to ensure that recording and traceability obligations are upheld throughout the entire production process and records are kept for a sufficient time after the sprouts can be assumed to have been consumed. Traceability codes or numbers printed on the packaging material may facilitate recalls in the event that food contamination occurs.
If one or several batches are known or assumed to be contaminated and these batches are no longer under the control of the sprout producer, the sprout producer must immediately take the initiative to contact the buyers to whom the products have been supplied. Batches known or assumed to be contaminated must be immediately withdrawn from the supply chain. The sprout producer must also notify the competent authority.
Where sprouts have already been distributed to consumers, sprout producers must inform these consumers that unsafe food may have been distributed to them. Sprout producers must inform consumers of the reason for the recall and where necessary, physically recall the food from the final consumers. However, depending on the case at hand, it is not always necessary that products are physically recalled from final consumers if other measures are sufficient to protect public health.
When managing a food recall situation, sprout producers must collaborate with the competent authorities on actions taken to avoid or reduce risks posed by the supply of the sprouts.
It is recommended that sprout producers lay down written recall procedures to follow in cases where contamination occurs. These rules should be easily accessible for all employees and covered in training programmes for staff members. Where no written recall rules exist, one staff member with knowledge of recall procedures must be available at all times.
The seed supplier should be contacted so that he/she can follow up possible shipments of the same seed batch seeds to other sprout producers. In this case, recall of the seeds may be necessary. Also, sprout producers should take measures and increase monitoring to find the cause of the contamination (the water, the environment, the staff, etc.). Sprout producers should keep the testing results on record for sufficient time after the sprouts can be assumed to have been consumed. It is recommended to keep all testing results on record for sufficient time so that they can be shown to competent authorities during official controls.
1.K. Traceability and record keeping
Commission Implementing Regulation (EU) No 208/2013 establishes specific traceability requirements for seeds for sprouting and sprouts. If sprouts are exempted from the requirements listed under this regulation, then still the Regulation (EC) No 178/2002 applies (more in detail in point 1.K.3.).
The traceability rules are designed to increase food safety because they allow tracing of food products through all stages of production, processing and distribution and make it possible to react rapidly in case of outbreaks of food-borne disease.
1.K.1. Process traceability in the sprouting establishment
Sprout producers should put in place a system to ensure traceability of the batches from the moment of arrival of the seeds until the moment of dispatch of the sprouts. It should be possible at any moment during the physical flow of the production process to know which batch of sprouts originates from which immediate supplier. This can be achieved by assigning codes or numbers to the batches of seeds received, or by defining smaller batches to which codes or numbers are assigned. These codes should then be maintained until the sprouts have been packaged and dispatched. If batches are re-organised or consolidated, due care should be taken to ensure that the link between the original batch of seeds and the re-organised or consolidated batches is upheld. Appropriate records should be kept for a sufficient time after the sprouts can be assumed to have been consumed.
1.K.2. Traceability requirements of final product — sprouts
Point 1.C.2. lists traceability requirements regarding controls of incoming seeds.
The food business operator producing the seed for sprouting has to transmit information to the food business operator producing the sprouts. The food business operator sprouting the seeds needs to keep records of origin of seeds and transmit this information to the next food business operator. Records should be kept at all stages.
The final product, sprouts, must comply with the legal traceability requirements set in the Regulation (EC) No 178/2002.
The sprout producer has to ensure that all information required in Commission Implementing Regulation (EU) No 208/2013, article 3(1) is transmitted to the food business operator to whom the sprouts are supplied. The following elements should be indicated:
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— |
name of the product including the Latin name (taxonomic name); |
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— |
identification number or equivalent batch reference; |
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— |
name of the supplier; |
|
— |
name and address of the recipient; |
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— |
if a forwarder or agent is used: name and address of the agent or forwarder; |
|
— |
date of shipping; |
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— |
quantity supplied. |
Sprout producers should keep a copy of this document on record for a sufficient time after the sprouts can be assumed to have been consumed. A copy of the document should be provided to the buyer.
National legislation in some Member States may impose additional traceability requirements that are not mentioned in this guideline. In case of uncertainty, it is recommended that sprout producers contact their competent authority to obtain more information about the national requirements.
All records mentioned in this chapter must be updated every day to take account of the latest incoming and outgoing shipments. Records can be kept in any appropriate form as long as they are easily retrievable and understandable for competent authorities in cases it is required. Where authorities require information, this must be provided without delay.
Alternative systems may also be feasible to ensure appropriate traceability. Some private electronic traceability schemes have been developed in the recent past, including Trace, IRIS, EPCIS, Fosstrak (Open Source) and some systems based on SAP (system application and product for data processing).
1.K.3. Exemption from the requirements in this chapter
As stated in Article 1 of Commission Implementing Regulation (EU) No 208/2013, sprouts that have undergone a treatment which eliminates microbiological hazards, compatible with European legislation, do not need to comply with this regulation (more about microbiological decontamination of seeds in point 1.G.2.). However, sprout producers are still under obligation by the General Food Law (Regulation (EC) No 178/2002, Article 18(3)) to have systems and procedures in place to identify businesses to which their products have been supplied – even for those products that have undergone a microbiological treatment.
1.L. Summary: Recording obligation
Throughout the production process, producers are asked to record and have available the following information (in any appropriate form as long as it is easily retrievable and understandable for competent authorities):
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1. |
Establishment and maintenance of the sprouting facility:
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2. |
Incoming seeds (to be kept for sufficient time until the final product can be assumed to have been consumed):
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3. |
Microbiological testing (to be kept for sufficient time until the final product can be assumed to have been consumed):
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4. |
Process traceability (to be kept for sufficient time until the final product can be assumed to have been consumed):
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5. |
Outgoing sprouts (to be kept for sufficient time until the final product can be assumed to have been consumed):
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6. |
Withdrawal and recall:
|
2. PRODUCTION OF SEEDS
Context
The pursuit of a high level of protection of human life and health is one of the fundamental objectives of Regulation (EC) No 852/2004. That Regulation constitutes a common basis for the hygienic production of all food.
2.A. General
All equipment should be cleaned regularly to prevent potential contamination from dust, insects and animals (with particular regard to faeces). Where possible, a diary should be maintained of the maintenance of all equipment.
Different methods:
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|
|
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Mechanical or hand drilling Broadcast of seeds by hand |
Combined harvest By hand pulling ripe pods from plants Undercut of plants |
2.B. Soil/land treatments
Grazing or potential ingress by wild and domestic animals should be avoided, and preventive measures such as fences or nets should be put in place by producers.
Fertilizers should only be applied in sufficient amounts to meet the needs of growth of plants for seeds. Organic fertilizers are widely and beneficially applied to meet seeds' nutrient requirements and improve soil fertility, but their incorrect use can be a source of both microbiological and chemical contamination. Pathogens may be present in manure and other natural fertilizers and may persist for weeks or even months, particularly if treatment of these materials is inadequate.
Physical, chemical or biological treatment methods (e.g. composting, pasteurization, heat drying, UV irradiation, alkali digestion, sun drying or combinations of these) may be used to reduce the risk of potential human pathogen survival in manure, sewage sludge and other organic fertilizers.
Organic fertilisers should not therefore contain microbial, physical or chemical contaminants at levels that may adversely affect the safety of fresh fruit and vegetables and their use must comply with the relevant EU regulations and take account of WHO guidelines (45) on the safe use of wastewater and excreta in agriculture, as appropriate.
Producers should use plant protection products in compliance with the label instructions of the individual products. Only authorised plant protection products should be used.
A diary should be maintained of the treatments used. Products and advice how to treat soil/land should be sourced from qualified professionals.
2.C. Worker hygiene
All workers should be aware of the basic principles of hygiene and health, and should be informed about all the dangers that could contaminate the seeds.
Staff should maintain good personal hygiene conditions at all stages of harvest and processing. Staff members known or suspected to have a disease or illness that can be transmitted to the seeds should not be allowed into areas where they may come into direct or indirect contact with seeds or sprouts. Staff members should immediately inform the management if they believe that they might have a relevant illness or have recovered from a relevant infectious disease but continuing to shed the microorganisms.
Staff injuries that could present a danger of contamination should be adequately treated with waterproof detectable covers before the worker can come into contact with seeds. Where possible, wounded workers should avoid direct contact with seeds or sprouts for human consumption.
Workers should have and use adequate sanitary facilities (incl. hand-washing facilities) available where feasible and necessary, e.g. when seeds are not in pods and workers are in direct contact with them. Where viable, workers should have clean uniforms. They must wash hands when starting, when needed during the day and at least each time the toilet was visited.
2.D. Irrigation
Several parameters may influence the risk of microbiological contamination of seeds: source of water, type of irrigation, the method of application of a water treatment by the grower, the timing of irrigation in relation to harvesting, possible access of animals to the source of water or production area.
Where the risk exists that irrigation water will get in a contact with pods, special care should be taken to make sure that the quality of water is at least of clean water.
All animal access to water sources and pumping areas should be controlled.
2.E. Seeds
Producers must use seed for sowing from a recognized source, with a proven track record. Due regard should be made for seeds with good germination, which are free of disease, physical damages or other affects that are potentially adverse to a successful harvest of healthy beans. Where feasible and affordable producers should conduct analyses and pre-treatments to ensure seeds are of suitable quality.
2.F. Drying of plants/pods
There are different practices applied among producing countries. In some countries, it is necessary to dry the pods before threshing. In this case a clean tarpaulin should be used between the drying pods and the earth. Due care should be taken to prevent potential contamination whilst the pods are vulnerable and such drying should be made in a designated area that prevents the access of wild animals and birds. In other countries plants are harvested and threshed mechanically, and so there are different methods used.
2.G. Threshing
It should be made mechanically on suitably maintained and cleaned equipment. Machines should be cleaned promptly after the end of the season, and also prior to the beginning of the next season, and where viable between each batch. Equipment should be stored in a covered area to protect the integrity of the equipment. During or immediately after threshing the seeds should be packed.
2.H. Storage after harvesting
Goods should be stored where viable – practically and economically – in new sound bags, and not in used or second hand bags. Also producers should consider whether it is necessary to cover the tops of storage piles with plastic sheets to protect the goods.
Storage areas and equipment should be cleaned and well maintained to prevent ingress and contamination from weather, animals and pests.
If stored in bulk, then clean tarpaulins should be used both under and on top of the goods and between goods and the wall, if applicable.
2.I. Processing
Goods should be processed at professional seed processing facilities with suitable equipment, which should include:
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— |
size grading, Gravity/Densimetric tables, destoners, magnets or metal detectors, and preferably colour sorters; |
|
— |
all equipment should be regularly cleaned to prevent cross contamination of other products, and due attention should be paid to hygiene; |
|
— |
staff should have adequate toilet & hand washing facilities (incl. soap) available, and where viable clean uniforms; |
|
— |
local area should be maintained to prevent dust & dirt, insects, animals and birds; |
|
— |
where viable, processors should have plans and keep records of contamination preventions. Mixing of batches should be as limited as is possible, and where viable restricted to similar growing regions; |
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— |
processors should have records available of where incoming seeds originated from. |
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— |
a quality regime implemented by trained staff to HACCP standard is recommended. Finished goods should be analysed according to buyers' requirements prior to shipment. |
(1) European Commission, DG Health and Food Safety. Food hygiene. Guidance
(2) Definition as set by the European Commission in Commission Implementing Regulation (EU) No 208/2013
(3) Definition set by the European Commission in Regulation (EU) No 852/2004
(4) Idem note 3.
(5) Definition as set by the European Commission in Commission Regulation (EU) No 211/2013
(6) Idem note 3.
(7) EFSA ‘Scientific Opinion on the risk posed by Shiga toxin-producing Escherichia coli (STEC) and other pathogenic bacteria in seeds and sprouted seeds’.
(8) Definition set by Codex Alimentarius Commission. Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application
(9) Idem note 3.
(10) Definition as set by the European Commission in Regulation (EC) No 396/2005
(11) ESSA definition based on Commission in Regulation (EC) No 2073/2005
(12) Definition set by the European Commission in Regulation (EC) No 178/2002
(13) Idem note 12.
(14) Idem note 3.
(15) Idem note 12.
(16) Idem note 12.
(17) Idem note 8.
(18) Definition set by Codex Alimentarius Commission. Recommended international code of practice general principles of food hygiene
(19) Definition set by the European Commission in Regulation (EU) No 1169/2011
(20) Idem note 11.
(21) Idem note 8.
(22) Idem note 3.
(23) Idem note 3.
(24) Idem note 3.
(25) Idem note 3.
(26) Idem note 3.
(27) Idem note 11.
(28) Idem note 11.
(29) Idem note 12.
(30) Idem note 12.
(31) Idem note 11.
(32) ESSA definition based on EFSA ‘Scientific Opinion on the risk posed by Shiga toxin-producing Escherichia coli (STEC) and other pathogenic bacteria in seeds and sprouted seeds’.
(33) Definition set by Codex Alimentarius Commission. Code of hygienic practice for fresh fruit and vegetables
(34) Idem note 7.
(35) Idem note 7.
(36) Idem note 7.
(37) Idem note 2.
(38) ESSA definition based on EFSA ‘Scientific Opinion on the risk posed by Shiga toxin-producing Escherichia coli (STEC) and other pathogenic bacteria in seeds and sprouted seeds’.
(39) Idem note 33.
(40) ESSA definition based on the definition of ‘seeds distributor’.
(41) Definition set by the European Commission in Regulation (EC) No 1107/2009
(42) Idem note 12.
(43) Commission Notice on the implementation of food safety management systems covering prerequisite programs (PRPs) and procedures based on the HACCP principles, including the facilitation/flexibility of the implementation in certain food businesses.
(44) Idem note 7.
(45) WHO Guidelines for the safe use of waste water, excreta and greywater.
ANNEX I
General legislation and specific legislation on sprouts
General legislation
These documents are available in all European Union languages:
|
— |
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (General Food Law). |
|
— |
Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs. |
|
— |
Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. |
|
— |
Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption. |
|
— |
Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs. |
|
— |
Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of information to consumers. |
|
— |
Delegated Regulation (EU) No 1062/2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council. |
|
— |
Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC |
Specific legislation on sprouts
These documents are available in all European Union languages:
|
— |
Commission Implementing Regulation (EU) No 208/2013 of 11 March 2013 on traceability requirements for sprouts and seeds intended for the production of sprouts. |
|
— |
Commission Regulation (EU) No 209/2013 of 11 March 2013 amending Regulation (EC) No 2073/2005 as regards microbiological criteria for sprouts and the sampling rules for poultry carcasses and fresh poultry meat. |
|
— |
Commission Regulation (EU) No 210/2013 of 11 March 2013 on the approval of establishments producing sprouts pursuant to Regulation (EC) No 852/2004 of the European Parliament and of the Council. |
|
— |
Commission Regulation (EU) No 211/2013 of 11 March 2013 on certification requirements for imports into the Union of sprouts and seeds intended for the production of sprouts, amended by Commission Regulation (EU) No 704/2014 on certification requirements for import into the Union of sprouts and seeds intended for the production of sprouts. |
ANNEX II
References to other relevant sources of information
|
— |
European Commission Guidance document on the implementation of procedures based on the HACCP principles, and on the facilitation of the implementation of the HACCP principles in certain food businesses. |
|
— |
Commission Notice on the implementation of food safety management systems covering prerequisite programs (PRPs) and procedures based on the HACCP principles, including the facilitation/flexibility of the implementation in certain food businesses (2016/C 278/01). |
|
— |
Codex general principles of food hygiene. This document includes a section on the application of the HACCP principles. |
|
— |
Code of Hygienic Practice for Fresh Fruits and Vegetables. Annex II for sprout production. |
|
— |
International Standards Organisation (ISO). ISO 22000 - Food safety management. International guidance with requirements for a food safety management system. |
|
— |
International Featured Standards (IFS) |
|
— |
European Commission Guidance Document (Commission staff working document) on Listeria monocytogenes shelf-life studies for ready-to-eat foods, under Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs. This is an informational document directed at food business operators in the EU. |
|
— |
EFSA Scientific Opinion on the risk posed by Shiga toxin-producing Escherichia coli (STEC) and other pathogenic bacteria in seeds and sprouted seeds. |
|
— |
WHO Guidelines for drinking water quality. |
|
— |
WHO Guidelines for the safe use of wastewater, excreta and greywater. |
|
8.7.2017 |
EN |
Official Journal of the European Union |
C 220/53 |
Non-opposition to a notified concentration
(Case M.8242 — Rolls-Royce/ITP)
(Text with EEA relevance)
(2017/C 220/04)
On 19 April 2017, the Commission decided not to oppose the above notified concentration and to declare it compatible with the internal market. This decision is based on Article 6(1)(b) in conjunction with Article 6(2) of Council Regulation (EC) No. 139/2004 (1). The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:
|
— |
in the merger section of the Competition website of the Commission (http://ec.europa.eu/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes, |
|
— |
in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32017M8242. EUR-Lex is the online access to European law. |
|
8.7.2017 |
EN |
Official Journal of the European Union |
C 220/53 |
Non-opposition to a notified concentration
(Case M.8465 — Vivendi/Telecom Italia)
(Text with EEA relevance)
(2017/C 220/05)
On 30 May 2017, the Commission decided not to oppose the above notified concentration and to declare it compatible with the internal market. This decision is based on Article 6(1)(b) in conjunction with Article 6(2) of Council Regulation (EC) No 139/2004 (1). The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:
|
— |
in the merger section of the Competition website of the Commission (http://ec.europa.eu/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes, |
|
— |
in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32017M8465. EUR-Lex is the online access to European law. |
|
8.7.2017 |
EN |
Official Journal of the European Union |
C 220/54 |
Non-opposition to a notified concentration
(Case M.8510 — Robert Tönnies/Clemens Tönnies/Zur Mühlen Group and Asset Group)
(Text with EEA relevance)
(2017/C 220/06)
On 27 June 2017, the Commission decided not to oppose the above notified concentration and to declare it compatible with the internal market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004 (1). The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:
|
— |
in the merger section of the Competition website of the Commission (http://ec.europa.eu/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes, |
|
— |
in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32017M8510. EUR-Lex is the online access to European law. |
IV Notices
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
European Commission
|
8.7.2017 |
EN |
Official Journal of the European Union |
C 220/55 |
Euro exchange rates (1)
7 July 2017
(2017/C 220/07)
1 euro =
|
|
Currency |
Exchange rate |
|
USD |
US dollar |
1,1412 |
|
JPY |
Japanese yen |
129,80 |
|
DKK |
Danish krone |
7,4371 |
|
GBP |
Pound sterling |
0,88488 |
|
SEK |
Swedish krona |
9,6155 |
|
CHF |
Swiss franc |
1,0983 |
|
ISK |
Iceland króna |
|
|
NOK |
Norwegian krone |
9,5613 |
|
BGN |
Bulgarian lev |
1,9558 |
|
CZK |
Czech koruna |
26,079 |
|
HUF |
Hungarian forint |
308,38 |
|
PLN |
Polish zloty |
4,2322 |
|
RON |
Romanian leu |
4,5862 |
|
TRY |
Turkish lira |
4,1465 |
|
AUD |
Australian dollar |
1,5006 |
|
CAD |
Canadian dollar |
1,4806 |
|
HKD |
Hong Kong dollar |
8,9140 |
|
NZD |
New Zealand dollar |
1,5669 |
|
SGD |
Singapore dollar |
1,5761 |
|
KRW |
South Korean won |
1 318,10 |
|
ZAR |
South African rand |
15,2646 |
|
CNY |
Chinese yuan renminbi |
7,7590 |
|
HRK |
Croatian kuna |
7,4153 |
|
IDR |
Indonesian rupiah |
15 300,60 |
|
MYR |
Malaysian ringgit |
4,9054 |
|
PHP |
Philippine peso |
57,786 |
|
RUB |
Russian rouble |
68,9193 |
|
THB |
Thai baht |
38,892 |
|
BRL |
Brazilian real |
3,7587 |
|
MXN |
Mexican peso |
20,7488 |
|
INR |
Indian rupee |
73,6955 |
(1) Source: reference exchange rate published by the ECB.
|
8.7.2017 |
EN |
Official Journal of the European Union |
C 220/56 |
List of organisations recognised on the basis of Regulation (EC) No 391/2009 of the European Parliament and of the Council on common rules and standards for ship inspection and survey organisations
(2017/C 220/08)
|
— |
American Bureau of Shipping (ABS) |
|
— |
Bureau Veritas Marine & Offshore SAS (BV) |
|
— |
China Classification Society (CCS) |
|
— |
Croatian Register of Shipping (CRS) |
|
— |
DNV GL AS |
|
— |
Indian Register of Shipping (IRS) |
|
— |
KR (Korean Register) |
|
— |
Lloyd’s Register Group Ltd (LR) |
|
— |
Nippon Kaiji Kyokai General Incorporated Foundation (ClassNK) |
|
— |
Polish Register of Shipping (PRS) |
|
— |
RINA Services S.p.A. |
|
— |
Russian Maritime Register of Shipping (RS) |
NOTICES FROM MEMBER STATES
|
8.7.2017 |
EN |
Official Journal of the European Union |
C 220/57 |
Commission information notice pursuant to Article 16(4) of Regulation (EC) No 1008/2008 of the European Parliament and of the Council on common rules for the operation of air services in the Community
Establishment of public service obligations in respect of scheduled air services
(Text with EEA relevance)
(2017/C 220/09)
|
Member State |
Italy |
||||||||||||||||
|
Routes concerned |
Alghero-Rome Fiumicino and vice versa Alghero-Milan Linate and vice versa Cagliari-Rome Fiumicino and vice versa Cagliari-Milan Linate and vice versa Olbia-Rome Fiumicino and vice versa Olbia-Milan Linate and vice versa |
||||||||||||||||
|
New date of entry into force of the public service obligations |
9 November 2017 |
||||||||||||||||
|
Address where the text and any information and/or documentation relating to the public service obligation can be obtained |
Reference document For further information, please contact:
|
|
8.7.2017 |
EN |
Official Journal of the European Union |
C 220/58 |
Commission information notice pursuant to Article 17(5) of Regulation (EC) No 1008/2008 of the European Parliament and of the Council on common rules for the operation of air services in the Community
Invitation to tender in respect of the operation of scheduled air services in accordance with public service obligations
(Text with EEA relevance)
(2017/C 220/10)
|
Member State |
Italy |
||||||||||||||
|
Route concerned |
Alghero-Rome Fiumicino and vice versa |
||||||||||||||
|
New period of validity of the contract |
A period of 4 years starting on 9 November 2017 |
||||||||||||||
|
Deadline for submission of tenders |
9 July 2017 |
||||||||||||||
|
Address from which the text of the invitation to tender and any relevant information and/or documentation relating to the public tender and the public service obligation can be obtained |
Reference document For further information please contact:
|
|
8.7.2017 |
EN |
Official Journal of the European Union |
C 220/59 |
Commission information notice pursuant to Article 17(5) of Regulation (EC) No 1008/2008 of the European Parliament and of the Council on common rules for the operation of air services in the Community
Invitation to tender in respect of the operation of scheduled air services in accordance with public service obligations
(Text with EEA relevance)
(2017/C 220/11)
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Member State |
Italy |
||||||||||||||
|
Route concerned |
Alghero-Milan Linate and vice versa |
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New period of validity of the contract |
A period of four years starting on 9 November 2017 |
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Deadline for submission of tenders |
9 July 2017 |
||||||||||||||
|
Address from which the text of the invitation to tender and any relevant information and/or documentation relating to the public tender and the public service obligation can be obtained |
Reference document For further information please contact:
|
|
8.7.2017 |
EN |
Official Journal of the European Union |
C 220/60 |
Commission information notice pursuant to Article 17(5) of Regulation (EC) No 1008/2008 of the European Parliament and of the Council on common rules for the operation of air services in the Community
Invitation to tender in respect of the operation of scheduled air services in accordance with public service obligations
(Text with EEA relevance)
(2017/C 220/12)
|
Member State |
Italy |
||||||||||||||
|
Route concerned |
Cagliari-Rome Fiumicino and vice versa |
||||||||||||||
|
New period of validity of the contract |
A period of 4 years starting on 9 November 2017 |
||||||||||||||
|
Deadline for submission of tenders |
9 July 2017 |
||||||||||||||
|
Address from which the text of the invitation to tender and any relevant information and/or documentation relating to the public tender and the public service obligation can be obtained |
Reference document For further information please contact:
|
|
8.7.2017 |
EN |
Official Journal of the European Union |
C 220/61 |
Commission information notice pursuant to Article 17(5) of Regulation (EC) No 1008/2008 of the European Parliament and of the Council on common rules for the operation of air services in the Community
Invitation to tender in respect of the operation of scheduled air services in accordance with public service obligations
(Text with EEA relevance)
(2017/C 220/13)
|
Member State |
Italy |
||||||||||||||
|
Route concerned |
Cagliari-Milan Linate and vice versa |
||||||||||||||
|
New period of validity of the contract |
A period of four years starting on 9 November 2017 |
||||||||||||||
|
Deadline for submission of tenders |
9 July 2017 |
||||||||||||||
|
Address from which the text of the invitation to tender and any relevant information and/or documentation relating to the public tender and the public service obligation can be obtained |
Reference document For further information please contact:
|
|
8.7.2017 |
EN |
Official Journal of the European Union |
C 220/62 |
Commission information notice pursuant to Article 17(5) of Regulation (EC) No 1008/2008 of the European Parliament and of the Council on common rules for the operation of air services in the Community
Invitation to tender in respect of the operation of scheduled air services in accordance with public service obligations
(Text with EEA relevance)
(2017/C 220/14)
|
Member State |
Italy |
||||||||||||||
|
Route concerned |
Olbia-Rome Fiumicino and vice versa |
||||||||||||||
|
Period of validity of the contract |
A period of 4 years starting on 9 November 2017 |
||||||||||||||
|
Deadline for submission of tenders |
9 July 2017 |
||||||||||||||
|
Address from which the text of the invitation to tender and any relevant information and/or documentation relating to the public tender and the public service obligation can be obtained |
Reference document For further information please contact:
|
|
8.7.2017 |
EN |
Official Journal of the European Union |
C 220/63 |
Commission information notice pursuant to Article 17(5) of Regulation (EC) No 1008/2008 of the European Parliament and of the Council on common rules for the operation of air services in the Community
Invitation to tender in respect of the operation of scheduled air services in accordance with public service obligations
(Text with EEA relevance)
(2017/C 220/15)
|
Member State |
Italy |
||||||||||||||
|
Route concerned |
Olbia-Milan Linate and vice versa |
||||||||||||||
|
Period of validity of the contract |
A period of four years starting on 9 November 2017 |
||||||||||||||
|
Deadline for submission of tenders |
9 July 2017 |
||||||||||||||
|
Address from which the text of the invitation to tender and any relevant information and/or documentation relating to the public tender and the public service obligation can be obtained |
Reference document For further information please contact:
|
V Announcements
PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY
European Commission
|
8.7.2017 |
EN |
Official Journal of the European Union |
C 220/64 |
Prior notification of a concentration
(Case M.8528 — SEGRO/PSPIB/SELP/Morgane Portfolio)
Candidate case for simplified procedure
(Text with EEA relevance)
(2017/C 220/16)
|
1. |
On 29 June 2017, the Commission received notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertakings SEGRO plc (‘SEGRO’, United Kingdom) and Public Sector Pension Investment Board (‘PSPIB’, Canada) acquire within the meaning of Article 3(1)(b) of the Merger Regulation, through SEGRO European Logistics Partnership S.à r.l. (‘SELP’, Luxembourg), joint control over an income producing logistics asset (‘Morgane Portfolio’, France) by way of purchase of assets. |
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2. |
The business activities of the undertakings concerned are: — for SEGRO: ownership, asset management and development of modern warehousing and light industrial properties located around major conurbations and at key transportation hubs across a number of EU countries, — for PSPIB: investment of net contributions to the pension funds of the federal Public Service, the Canadian Forces, the Royal Canadian Mounted Police and the Reserve Force. It manages a diversified global portfolio including stocks, bonds and other fixed-income securities, and investments in private equity, real estate, infrastructure, natural resources and private debt, — for Morgane Portfolio: a logistics assets located in Nîmes, France. |
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3. |
On preliminary examination, the Commission finds that the notified transaction could fall within the scope of the Merger Regulation. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under the Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in this Notice. |
|
4. |
The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission. Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301), by email to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference M.8528 — SEGRO/PSPIB/SELP/Morgane Portfolio, to the following address:
|
(1) OJ L 24, 29.1.2004, p. 1 (the ‘Merger Regulation’).
(2) OJ C 366, 14.12.2013, p. 5.
|
8.7.2017 |
EN |
Official Journal of the European Union |
C 220/65 |
Prior notification of a concentration
(Case M.8557 — CCMP Capital/MSD Aqua Partners/Hayward Industries)
Candidate case for simplified procedure
(Text with EEA relevance)
(2017/C 220/17)
|
1. |
On 29 June 2017, the Commission received notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which CCMP Capital, LP (‘CCMP’, USA) and MSD Aqua Partners, LLC (‘MSD Aqua’, USA), controlled by MSD Partners LP (‘MSD Partners’, USA) and belonging to the MSD group of companies, indirectly acquire within the meaning of Article 3(1)(b) of the Merger Regulation joint control of Hayward Industries, Inc. (‘Hayward’, USA) by way of a purchase of shares. |
|
2. |
The business activities of the undertakings concerned are: — for CCMP: global private equity firm focused on making buyout and growth equity investments in North America and Europe in the consumer, industrial and healthcare industries, — for MSD Aqua: investment entity within the MSD group of companies which is active in the debt and equity of public and private companies, real estate and other asset classes, — for Hayward: manufacturer and supplier of swimming pool equipment. |
|
3. |
On preliminary examination, the Commission finds that the notified transaction could fall within the scope of the Merger Regulation. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under the Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in this Notice. |
|
4. |
The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission. Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301), by email to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference M.8557 — CCMP Capital/MSD Aqua Partners/Hayward Industries, to the following address:
|
(1) OJ L 24, 29.1.2004, p. 1 (the ‘Merger Regulation’).
(2) OJ C 366, 14.12.2013, p. 5.
|
8.7.2017 |
EN |
Official Journal of the European Union |
C 220/66 |
Prior notification of a concentration
(Case M.8356 — Wietersdorfer/Amiantit/HOBAS JV)
(Text with EEA relevance)
(2017/C 220/18)
|
1. |
On 29 June 2017, the Commission received notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertakings WIG Wietersdorfer Holding GmbH (‘WIG’, Austria) and Saudi Arabian Amiantit Company (‘Amiantit’, Saudi Arabia) acquire within the meaning of Article 3(1)(b) of the Merger Regulation joint control of HOBAS Pipes International GmbH (‘Hobas Europe’, Austria). Amiantit will contribute its European piping systems business into Hobas Europe, currently a wholly owned subsidiary of WIG, and acquire 50 % of its shares. |
|
2. |
The business activities of the undertakings concerned are: — for WIG: manufacture and sale of pipes and pipe systems designed for the transport of water (drainage, sewage, irrigation and potable pressure water) and, to a limited extent, for industrial use within various types of plants. WIG is active globally, — for Amiantit: manufacture and sale of pipes and pipe systems, sale of pipe technologies and the manufacture and supply of polymer products. Amiantit is active globally. Amiantit's European business is active in the production and sale of glass fiber reinforced plastic (GRP) pipes and pipe systems, — for Hobas Europe: manufacture and sale of GRP pipes and pipes systems in Europe. |
|
3. |
On preliminary examination, the Commission finds that the notified transaction could fall within the scope of the Merger Regulation. However, the final decision on this point is reserved. |
|
4. |
The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission. Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301), by email to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference M.8356 — Wietersdorfer/Amiantit/HOBAS JV to the following address:
|
(1) OJ L 24, 29.1.2004, p. 1 (the ‘Merger Regulation’).