EUROPEAN COMMISSION DIRECTORATE-GENERAL JOINT RESEARCH CENTRE. EURL ECVAM Scientific Advisory Committee ESAC RULES OF PROCEDURE EP3.

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1 EUROPEAN COMMISSION DIRECTORATE-GENERAL JOINT RESEARCH CENTRE Directorate F - Health, Consumers and Reference Materials European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) EURL ECVAM SCIENTIFIC ADVISORY COMMITTEE (ESAC) EP3.01 EURL ECVAM Scientific Advisory Committee (ESAC) RULES OF PROCEDURE Document information: EURL ECVAM/ESAC document ID File name EP3.01 ESAC RULES OF PROCEDURE 1 st version Adopted at ESAC32, April nd updated version Adopted at ESAC 36, March rd updated version Updated in December 2016; to be adopted at ESAC 43 once ESAC is renewed

2 TABLE OF CONTENTS 1. INTRODUCTION AND PURPOSE RULES OF PROCEDURE OF THE EURL ECVAM SCIENTIFIC ADVISORY COMMITTEE (ESAC)... 3 Article 1 Mandate of the ESAC... 3 Article 2 Membership, appointment, term of office... 4 Article 3 Other participants to the meetings... 5 Article 4 Decision taking by the ESAC... 5 Article 5 Election of Chair and Vice Chair... 6 Article 6 Responsibilities of the Chair and Vice Chair... 6 Article 7 ESAC Rapporteurs... 6 Article 8 ESAC Working Groups... 7 Article 9 Declaration of commitment... 7 Article 10 Declaration of interests... 7 Article 11 Declaration of confidentiality... 8 Article 12 Transparency... 8 Article 13 Meetings, documentation to the meetings, agendas, minutes... 9 Article 14 Written procedure...10 Article 15 Fees and reimbursements...10 Article 16 General provisions...10 Article 17 Protection of personal data REFERENCES...11 ANNEX I DECLARATION OF COMMITMENT OF CORE ESAC MEMBERS...13 ANNEX II DECLARATION OF COMMITMENT OF AD HOC ESAC MEMBERS...14 ANNEX III DECLARATION OF INTERESTS OF ESAC MEMBERS...15 ANNEX IV DECLARATION CONCERNING CONFIDENTIALITY OF ESAC MEMBERS AND OBSERVERS...18 EP3.01 Rules of Procedure of the ESAC Page 2 of 18

3 1. INTRODUCTION AND PURPOSE The EURL ECVAM Scientific Advisory Committee (hereinafter referred to as ESAC) advises EURL ECVAM on scientific issues. ESAC's main role is to conduct independent peer reviews of validation studies of alternative test methods, assessing their scientific validity for a given purpose. The ESAC reviews the appropriateness of study design and management, the quality of the results obtained and the plausibility of the conclusions drawn. ESAC peer reviews are formally initiated with a EURL ECVAM Request for ESAC Advice (hereinafter referred to as Request), which provides the necessary background for the peer-review and establishes its objectives, timelines and the questions to be addressed. The peer reviews are normally prepared by specialised ESAC Working Groups (hereinafter referred to as EWGs). These are composed of core ESAC members and ad hoc ESAC members selected based on their expertise on the test method(s) and/or scientific question(s) under review. The experts acting as ad hoc ESAC members may be nominated by the core ESAC, EURL ECVAM and partner organisations within the International Cooperation on Alternative Test Methods (ICATM). The final composition of the EWGs and the appointment of ad hoc members must be agreed between EURL ECVAM and the core members of ESAC. ESAC's advice to EURL ECVAM is formally provided as EWG Reports and ESAC Opinions at the end of the peer review. The ESAC may also issue Opinions on other scientific matters of relevance to the work and mission of EURL ECVAM. These Rules of Procedure (RoP) outline the role and the duties of the ESAC, and lay down the rules that govern its functioning and operation. 2. RULES OF PROCEDURE OF THE EURL ECVAM SCIENTIFIC ADVISORY COMMITTEE (ESAC) Article 1 Mandate of the ESAC 1. Upon Request by EURL ECVAM, the ESAC shall provide EURL ECVAM with independent scientific advice in the form of ESAC Opinions on alternative test methods and, in particular, on the scientific validity of alternative test methods which have been the subject of a validation study. Concerning the latter, the ESAC shall peer review reports from validation studies (incl. relevant background documentation) which evaluated the scientific validity of test methods in view of their stated purpose. On this basis the ESAC shall address in its Opinions the reliability and the relevance of validated alternative test methods for their specified purpose. To the extent possible the Opinions shall also outline the applicability and limitations of the validated test methods, determining their scientifically justified use in view of the stated purpose. 2. When providing advice, the ESAC shall respond to the specific mandate formulated by EURL ECVAM in its Request. The mandate clearly frames the questions put forward to the ESAC by EURL ECVAM and will be part of specific Terms of Reference pertaining to each Request from EURL ECVAM to ESAC in which the objective, the task, the deliverable(s) and the timelines are outlined. 3. ESAC Opinions shall be based primarily on the data reported in the validation study reports made available by EURL ECVAM and for which peer reviewing is requested. ESAC may take other relevant scientific information into account which should be clearly referred to in its Opinion. Specialised EWGs shall carry out the peer reviews of validation study reports and prepare draft EWG Reports and draft ESAC Opinions. 4. Adopted ESAC Opinions are published on the JRC Publications Repository ( and on the EURL ECVAM website as individual documents following a specific JRC Technical Report template, including as annexes and where applicable (i) the composition of the core ESAC and of the EWG or Rapporteur(s) responsible for EP3.01 Rules of Procedure of the ESAC Page 3 of 18

4 conducting the peer-review, (ii) the EURL ECVAM Request for ESAC Advice, and (iii) the adopted EWG Report. 5. Adopted ESAC Opinions are the most important basis for the development of formal EURL ECVAM Recommendations. These Recommendations include advice regarding possible regulatory applicability, limitations and proper scientific use of the test method. 6. Upon Request, ESAC may also provide scientific advice on any other issue of relevance to the work and mission of EURL ECVAM. 7. The working language of the EWGs and ESAC is English, the working documents are in English and the meetings are also conducted in English. Article 2 Membership, appointment, term of office 1. The ESAC is composed of core and ad hoc members (hereinafter jointly referred to as Members). 2. Core members are appointed by the Director of the EC-JRC Directorate F Health, Consumers and Reference Materials on the basis of a Call for Applications, and from a shortlist of suitable candidates established by a Selection Committee consisting of EURL ECVAM staff and representatives from other Commission services. In preparing its proposal, the Selection Committee shall apply pre-defined eligibility and selection criteria, published in the Call for Applications. 3. Core members are appointed as individual experts on the basis of their qualifications/expertise and other skills relevant for committee work. They therefore shall not have alternates. 4. The term of office of the core members shall be up to three years, starting on the date of their appointment. The appointment may be renewed once at most (two consecutive terms). Core members may however serve more than two terms as long as these are not consecutive. 5. A core member s term of office can end before the expiry of the three-year period with his or her resignation, submitted in writing to EURL ECVAM. Following a justified proposal from the Chair, the Director of Directorate F may ask a core member to resign if he/she is not able to fulfil his/her duties. 6. Resigned core members may be replaced at any point in time by appointment of new core members by the Director of Directorate F, either from the previously established shortlist or on the basis of a new Call for Applications followed by a selection procedure. 7. External experts selected to serve in EWGs based on their expertise on the test method(s) and/or scientific question(s) under review are considered ad hoc members. Ad hoc members are appointed as individual experts on the basis of their qualifications/expertise and other skills relevant for committee work and must satisfy the same eligibility criteria used in the selection of the core members. 8. The experts acting as ad hoc members may be nominated by the core ESAC, EURL ECVAM and partner organisations within the International Cooperation on Alternative Test Methods (ICATM). 9. The term of office of an ad hoc member begins with his/her official appointment as member of an EWG and finishes on the adoption by ESAC of the EWG Report(s) and ESAC Opinion(s) to which the ad hoc member contributed through his/her participation in the EWG. 10. Ad hoc members are invited to participate in those ESAC plenary meetings where the draft EWG Report(s) and draft ESAC Opinion(s) to which the ad hoc member contributed (through the EWG) are discussed and eventually adopted. During their term of office, ad hoc members have the same status as core members when it comes to voting on scientific issues they helped peer-review (see Article 4), but not on other issues for which they did not contribute through their EWG membership. EP3.01 Rules of Procedure of the ESAC Page 4 of 18

5 Article 3 Other participants to the meetings The meetings of the ESAC and EWGs shall be open to Observers invited by EURL ECVAM. EURL ECVAM may invite as Observers one representative from each member and observer organisation of ICATM 1 (currently 2 NICEATM/ICCVAM 3 (USA), JaCVAM 4 (Japan), Health Canada, KoCVAM 5 (Korea), BraCVAM 6 (Brazil) and the Chinese Food and Drug Administration), a representative of the OECD 7 Test Guidelines Programme and representatives from other Commission services, such as the Directorate Generals Joint Research Centre (JRC), Environment (ENV), Health and Food Safety (SANTE) and Internal Market, Industry, Entrepreneurship and SMEs (GROWTH). Observers shall have full access to meeting documents as ESAC Members, except in relation to issues that the Chair identifies as confidential or where their participation is excluded. The Chair may, upon solicitation of at least one ESAC Member and in agreement with the ESAC, exclude Observers from the discussion of certain agenda points. 1. Quorum 2. Voting rights Article 4 Decision taking by the ESAC a. The quorum for adopting Opinions is achieved when at least 2/3 rd of the core members are participating. b. Members having declared a conflict of interest in agreement with Article 10 shall not be regarded as part of the quorum regarding the particular agenda point. Only Members have voting rights. Members cannot vote on issues for which they have declared a conflict of interest. 3. Decision taking regarding ESAC Opinions a. The ESAC shall adopt its Opinions by consensus in the plenary or by written procedure. b. If consensus cannot be reached, the Opinion adopted by the ESAC shall consist of the position of the absolute majority 8 of all Members. The position of the minority including an explanation of the grounds for it should be attached to the minutes of the meeting or the report on the written procedure. 4. Decision taking with regard to procedural issues Unless these Rules of Procedure specify otherwise, decisions on any procedural issues need to be supported by a simple majority 9. 1 International Cooperation on Alternative Test Methods (ICATM). The ICATM framework was initiated in 2007 and agreed upon in 2008 by the International Cooperation on Cosmetics Regulation (ICCR). A formal Memorandum of Cooperation (MoC) on the agreed ICATM framework was signed by ECVAM (EU), NICEATM (US), JaCVAM (Japan) and Health Canada in In 2011, KoCVAM (South Korea) joined the ICATM and an updated MoC was signed by all partners. 2 As of December The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Interagency Coordinating Committee for the Validation of Alternative Methods (ICCVAM) 4 Japanese Center for the Validation of Alternative Methods (JaCVAM) 5 Korean Center for the Validation of Alterantive Methods (KoCVAM) 6 Brazilian Center for Validation of Alternative Methods (BraCVAM) 7 Organisation for Economic Co-Operation and Development (OECD) 8 Absolute majority = majority of all eligible to vote 9 Simple majority = majority of the votes EP3.01 Rules of Procedure of the ESAC Page 5 of 18

6 Article 5 Election of Chair and Vice Chair 1. ESAC shall elect from among its core members one Chair and one Vice Chair. 2. The Chair and Vice Chair have to receive 2/3 rd of the votes of all core members. 3. If none of the candidates receives 2/3 rd majority, an additional ballot shall be held between those two candidates that received the highest number of votes in the first ballot. The procedure shall be repeated until one candidate receives a 2/3 rd majority. 4. The terms of office of Chairs and Vice Chairs shall run for the duration of mandate of the ESAC. Article 6 Responsibilities of the Chair and Vice Chair The Chair, in cooperation with the Vice Chair and supported by the ESAC Coordinator from EURL ECVAM (hereinafter referred to as Coordinator), is responsible for the efficient conduct of the business of ESAC. In cooperation with the Vice Chair and the Coordinator the Chair shall in particular: a. Organise the work of the ESAC in order to secure the timely completion of tasks, in particular through proposing the agenda of meetings, and initiating written procedures; b. Ensure that the ESAC RoPs are respected and propose measures in case of breach; c. Ensure that at the beginning of each meeting potential conflicts of interests are declared; d. Facilitate the adoption of Opinions by consensus; e. Ensure the scientific consistency of ESAC Opinions; f. Ensure that ESAC Opinions are based on a thorough evaluation and documentation of all available information, clearly explaining and justifying the Opinion. Article 7 ESAC Rapporteurs 1. In case that no EWG is needed, ESAC may designate (an) ESAC Rapporteur(s) from among its core members for a specific issue on which it is requested to provide an Opinion. 2. ESAC Rapporteurs shall be responsible for assembling information and preparing draft ESAC Rapporteur Reports and draft ESAC Opinions on a given, clearly defined issue within their competence, and making them available to core members of ESAC within a set time period. 3. The Coordinator will prepare draft Terms of Reference for the Rapporteur(s), specifying the objective, the specific task, the deliverable(s) and timelines, which will be amended as necessary and adopted by the ESAC. 4. The Rapporteur(s) shall report back to ESAC, presenting the issue at stake and the proposed draft Opinion. 5. The Rapporteur(s) shall work in close cooperation with the Coordinator and the Chair. 6. The term of office of the Rapporteur(s) begins with his/her/their official appointment by the ESAC and finishes on the adoption by the ESAC of the ESAC Rapporteur Report(s) and ESAC Opinion(s) drafted by the Rapporteur(s). EP3.01 Rules of Procedure of the ESAC Page 6 of 18

7 1. Mandate of EWGs Article 8 ESAC Working Groups a. EWGs prepare draft EWG Reports and draft ESAC Opinions, or any other input to the ESAC, based on a mandate defined in a Request adopted by ESAC, clearly stating the task and its duration. b. This Request will be drafted by the Coordinator in agreement with the Chair and forms part of the EWG's Terms of Reference outlining the EWG's objective, task, deliverable(s) and timelines. c. The Terms of Reference should also specify the core member of ESAC chairing the EWG and define the composition of the EWG in question, either by naming its Members or by identifying the required expertise. In the latter case the Chair of the EWG, in all cases a core member of ESAC, shall be entrusted to identify, in agreement with the Coordinator, the appropriate EWG Members. 2. Membership, chairing, Observers a. Each EWG must comprise at least one core member of ESAC who shall chair the EWG. Otherwise, EWGs may be composed of any combination of core and ad hoc members. b. The EWG Chair, in close collaboration with the Coordinator, will organise the work of the group and secure the timely completion of deliverables. c. The ESAC may agree to allow the participation of Observers in the work of an EWG. Article 9 Declaration of commitment Members of the ESAC are obliged to make all reasonable efforts to fulfil their duties as Members. This includes reading all communications with care, attending the meetings to which they are invited, participating in the discussions and deliberations of the ESAC, acting independently in the public interest and adhering to the principle of excellence, i.e. all information made available to the Members shall be evaluated, assessed, discussed and judged solely on the grounds of logic and scientific evidence. Core members shall also support EURL ECVAM in identifying the most suitable experts for participation in EWGs (ad hoc members). To this end, at the time of their appointment, Members shall make a formal declaration of commitment (see Annexes I and II). Article 10 Declaration of interests 1. Members of the ESAC must act independently of any external influence and solely on the basis of scientific considerations. 2. To this end, Members shall make at their appointment a formal declaration of interests (see Annex III) in which all interests that might be considered prejudicial to the independence of the Member must be stated or, if appropriate, the absence of any such interests. This declaration shall be renewed at each ESAC meeting and EWG meeting, where required (see point 3 below). 3. Members and Observers shall declare at each meeting any interests which could be considered prejudicial to their independence with respect to any point on the agenda. Participants declaring such interests may only speak upon solicitation of the Chair and, if Members are concerned, shall not participate in any voting on the relevant agenda point nor count for the quorum. The Chair, in cooperation with the Vice Chair and the Coordinator, may decide whether other measures are necessary. In case of declared interests the Chair may, at any point in time, exclude specific participants from the plenary meeting or from written procedure. This may concern both Members and Observers. EP3.01 Rules of Procedure of the ESAC Page 7 of 18

8 4. Members who are approached by third parties in the context of their work in the ESAC shall report this contact to the Chair and Coordinator and share any related information with the ESAC. Article 11 Declaration of confidentiality 1. All Members and Observers shall not divulge any information acquired in the course of their participation in the ESAC or any of its Working Groups, especially with respect to information or data identified by the Chair or the Coordinator as 'confidential' or for 'restricted use'. To that end, all Members and Observers must sign at their appointment (Members) or first participation in an ESAC meeting or EWG meeting (Observers) a written declaration of confidentiality (see Annex IV). 2. All Members and Observers are obliged to maintain confidentiality even after their participation in the ESAC or one of its Working Groups has ceased unless the information in question becomes publicly available. 3. The ESAC may exclude Members or Observers from specific agenda points, entire meetings, or in general if their specific interest would conflict with the requirement of confidentiality. Article 12 Transparency 1. The ESAC will operate in a transparent manner without prejudice to legitimate demands for confidentiality. 2. Calls for access to documents will be treated in accordance with Regulation 1049/2001 (Ref. 1) of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents. 3. The following documents of the ESAC will be made public via the EURL ECVAM website a. These Rules of Procedure. b. Name, affiliation and brief scientific Curriculum Vitae (devoid of personal details and contact details) of each core ESAC member. c. Draft and final agendas of ESAC plenary meetings. d. Final minutes of the plenary meetings, including, if necessary, justified minority positions. e. Adopted ESAC Opinions, including as annexes and where applicable (i) the composition of the core ESAC and of the EWG or Rapporteur(s) responsible for conducting the peer-review, (ii) the EURL ECVAM Request for ESAC Advice, and (iii) the adopted EWG Report. ESAC Opinions (with their annexes) will also be published on the JRC Publications Repository ( 4. Preparatory and draft documents shall be available only to Members, the Coordinator, relevant EURL ECVAM staff and, as far as confidentiality considerations allow, also Observers. These documents shall not be made available to third parties, even if they do not contain information declared "confidential" or "for restricted use". EP3.01 Rules of Procedure of the ESAC Page 8 of 18

9 1. Meetings Article 13 Meetings, documentation to the meetings, agendas, minutes a. ESAC meetings are hosted by EURL ECVAM and are held on an as-needed basis, but typically the ESAC convenes once to twice per year. b. The meetings are convened by invitation by EURL ECVAM, sent by the Coordinator and signed by the appropriate Commission employee. c. Meeting dates for the following months will be discussed and eventually confirmed at each meeting. d. The invitation to the meetings shall be circulated by the Coordinator at least 1 month before the meetings. e. Registration for meetings must be done on-line through the web-based JRC Events Registration System ( and is compulsory for all participants. 2. Meeting documentation shall be made available for download from CIRCABC, a dedicated and password-protected website, at least 14 days before a meeting. 3. Agenda a. A provisional agenda shall be drawn up by the Chair and the Coordinator and circulated together with the invitations, followed by a draft agenda as soon as possible but not later than 14 days before a meeting. b. Members may ask at any time that items be put on the agenda. A final draft will be circulated no later than 10 days before the meeting. c. The final agenda shall be established by the Chair at the beginning of each meeting, taking due account of the feedback received from the Members, including suggestions for additional agenda points. The final agenda shall be adopted at the beginning of each meeting. 4. Format of minutes The minutes shall include: a. The final agenda and a summary record of the proceedings. b. Any eventual minority position and its justification (as annex). c. Any report on a written procedure adopted. d. Action points (as annex). e. Any specific interests declared by the participants to any point of the agenda and a record of the measures taken. f. The list of attendees. 5. Distribution and approval of minutes Minutes shall be distributed to the Members no later than 21 calendar days after the meeting by the Coordinator. Written comments shall be provided to the Coordinator within the specified deadline which shall be a minimum of 10 calendar days. The minutes shall be adopted by the Members at a subsequent meeting or through written procedure, prior to publication on the EURL ECVAM website. EP3.01 Rules of Procedure of the ESAC Page 9 of 18

10 Article 14 Written procedure 1. The Chair may ask the ESAC to adopt Opinions or to take other decisions by written procedure. To this end, the Coordinator shall make available to the Members the documents on which their Opinion is sought and indicate the response period. 2. This period shall normally not be shorter than 10 calendar days. In case of urgency, or if agreed beforehand by the ESAC, the period can be shortened to a minimum of five calendar days. 3. In case of adoption of Opinions by written procedure, at least 2/3 rd of the Members have to respond for the procedure to be regarded as valid. If the Opinion is not adopted by consensus of all responding Members, the position of the absolute majority of all Members is the position of the ESAC. The minority position(s), including their reasons, shall be duly recorded in the report on the written procedure to be established by the Coordinator and adopted by the ESAC at its next plenary meeting. 4. In case of taking other decisions than Opinions by written procedures, any Member who does not comment within the response period is considered to have given his/her tacit agreement to the proposed action. An action is agreed by consensus when all Members have agreed, expressively or tacitly. In the event of non-consensus, the position of the ESAC is the position of the absolute majority of all Members, and the minority position(s), including their reasons, shall be duly recorded in the report on the written procedure to be established by the Coordinator and adopted by the ESAC at its next plenary meeting. 5. In case major and justified objections are submitted to the Coordinator, the Chair shall decide, in cooperation with the Vice Chair and the Coordinator, whether the written procedure should be suspended and the adoption of the draft Opinion or decision postponed to the next plenary meeting of the ESAC. 6. The Coordinator shall inform the ESAC of the outcome of the written procedure and forward the written procedure report, including any Opinion or decisions (and minority positions if appropriate), to the ESAC, without undue delay after the end of the written procedure and for adoption at the next plenary. Article 15 Fees and reimbursements 1. The Joint Research Centre shall reimburse travel expenses and pay an accommodation allowance and, where appropriate, a daily allowance to Members for their participation in meetings at EURL ECVAM and, where appropriate, to other participants invited to attend those meetings, in accordance with the rules of the Commission on the reimbursement of travel and other expenses. 2. Non-governmental EWG members shall also be entitled to the payment of a flat fee (fixed daily rate) of a maximum of EUR 450, in line with the appropriate Commission rules, for each full day of work at EURL ECVAM during a dedicated EWG meeting, including related preparatory work. 3. Apart from reimbursement of travel expenses and payment of accommodation allowances and, where appropriate, daily allowances, no other fees will be paid for attendance to ESAC meetings. Article 16 General provisions The Rules of Procedure or any amendment to them shall apply from the date they have been adopted by the renewed ESAC during its first face-to-face meeting. EP3.01 Rules of Procedure of the ESAC Page 10 of 18

11 Article 17 Protection of personal data All processing of personal data for the purposes of these rules of procedure shall be in accordance with Regulation (EC) 45/2001of 30 May 2001 (OJ L 145, , p. 43). 3. REFERENCES (1) REGULATION (EC) No 1049/2001 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 May 2001 regarding public access to European Parliament, Council and Commission documents. Official Journal, L 145, p 43. EP3.01 Rules of Procedure of the ESAC Page 11 of 18

12 EUROPEAN COMMISSION DIRECTORATE-GENERAL JOINT RESEARCH CENTRE Directorate F - Health, Consumers and Reference Materials European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) EURL ECVAM SCIENTIFIC ADVISORY COMMITTEE (ESAC) ANNEXES DECLARATIONS OF COMMITMENT, INTEREST AND CONFIDENTIALITY Instructions for use: 1. Duly complete all declarations (preferably as a word file) and safe the file. 2. Print the completed file and sign all three declarations. 3. Scan the signed declarations 4. Send the scanned declarations to JRC-ECVAM-ESAC@ec.europa.eu indicating "DECLARATION" in the subject line.

13 ANNEX I DECLARATION OF COMMITMENT OF CORE ESAC MEMBERS I, hereby declare that I shall make all reasonable efforts to fulfil my duties as a core member of the EURL ECVAM Scientific Advisory Committee (ESAC). In particular I undertake to (1) read all relevant communication carefully and attend the meetings regularly; (2) contribute with my best scientific capacity to the deliberations in plenary meetings or through written procedure; (3) support EURL ECVAM in identifying the most suitable experts to act as ad hoc members of ESAC for specific ESAC Working Groups; (4) observe the timelines; (5) act independently in the public interest and adhere to the principle of excellence, i.e. evaluate, assess, discuss and judge all information made available to me in the course of my work as a Member of the ESAC solely on the grounds of the scientific evidence. I understand that this Declaration will be entered in a register held by the European Union Reference Laboratory for Alternatives to Animal Testing which is accessible to the public on the EURL ECVAM website ( Done at (place) on / / Signature: EP3.01 Rules of Procedure of the ESAC Page 13 of 18

14 ANNEX II DECLARATION OF COMMITMENT OF AD HOC ESAC MEMBERS I, hereby declare that I shall make all reasonable efforts to fulfil my duties as an ad hoc member of the EURL ECVAM Scientific Advisory Committee (ESAC) and as a member of the ESAC Working Group. In particular I undertake to (1) read all relevant communication carefully and attend the meetings to which I will be invited; (2) contribute with my best scientific capacity to the deliberations in plenary meetings or through written procedure; (3) observe the timelines; (4) act independently in the public interest and adhere to the principle of excellence, i.e. evaluate, assess, discuss and judge all information made available to me in the course of my work as an ad hoc member of the ESAC solely on the grounds of the scientific evidence. I understand that this Declaration will be entered in a register held by the European Union Reference Laboratory for Alternatives to Animal Testing which is accessible to the public on the EURL ECVAM website ( Done at (place) on / / Signature: EP3.01 Rules of Procedure of the ESAC Page 14 of 18

15 ANNEX III DECLARATION OF INTERESTS OF ESAC MEMBERS Title: First Name: Family Name: I herewith declare (1) not to seek or accept any instructions incompatible with my individual tasks or with the tasks of the ESAC from any other party, (2) make complete declarations of any direct or indirect interests that might be considered prejudicial to my independence. I hereby declare to have the following economic or ethical interests which might be considered prejudicial to my independence: 1. Direct interests 1.1 Work and activities in organisations 10 relevant to the operating area of EURL ECVAM during the past five years and at present: Name of organisation Position / Tasks Period 10 Examples (non-exhaustive) include: commercial enterprises developing and marketing alternative test methods or using such methods for internal hazard/risk assessments or for regulatory purposes; consultancy firms active, at least in part, in the area of alternative methods (e.g. providing consultancy services to third party organisations); academic research groups or research organisations involved in developing alternative test methods; civil society organisations active in the field of alternative methods. EP3.01 Rules of Procedure of the ESAC Page 15 of 18

16 1.2. Financial interests in a company 11 relevant to the operating area of EURL ECVAM during the past five years and at present: Name of organisation Position / Tasks Period 2. Indirect interests 2.1 Professional activities of family 12 members: 2.2 Membership roles or affiliation in bodies with an interest in the operating area of EURL ECVAM 13 : 2.3 Other interests or facts that the undersigned considers pertinent as a Member or Invited Expert of ESAC: 11 Examples (non-exhaustive) include: commercial enterprises developing and marketing alternative test methods or using such methods for internal hazard/risk assessments or for regulatory purposes; consultancy firms active, at least in part, in the area of alternative methods (e.g. providing consultancy services to third party organisations) 12 Family includes (a) immediate/conjugal family, i.e. spouse (including divorced partners), parent, child (including adopted children), sibling, (b) extended family, i.e. grandparent, aunt, uncle, nephew, niece, cousin, (c) family-in-law, i.e. father-, mother-, brother-, sister-, son-, daughter-in-law. 13 Examples (non-exhaustive) include: editorial boards of journals of an area related to alternative methods or their relevant scientific, applied or legal aspects; research organisations or learned societies; relevant civil society organisations etc. EP3.01 Rules of Procedure of the ESAC Page 16 of 18

17 Declaration: I declare that the information above is true and complete. I shall immediately and explicitly inform the Coordinator of any specific interest concerning any question submitted by the Commission on the occasion of the meeting at which the relevant question is to be examined by the ESAC. I shall inform the Coordinator of any change with regard to my interests which could be prejudicial to my independence. Done at (place) on / / Signature: EP3.01 Rules of Procedure of the ESAC Page 17 of 18

18 ANNEX IV DECLARATION CONCERNING CONFIDENTIALITY OF ESAC MEMBERS AND OBSERVERS I, hereby declare that I shall undertake to exercise the greatest discretion with regard to all facts and information coming to my knowledge in the course of or in connection with the performance of my duties as a Member/Observer* of the ESAC. I shall not disclose to any persons any information acquired as a result of my participation in the ESAC unless otherwise indicated/authorised by the Coordinator or otherwise stipulated in Community or relevant applicable National law or already publicly available. I accept without reservation that I continue to be bound by this obligation also after these duties have ceased. Done at (place) on / / Signature: *) Please strike through non-relevant text EP3.01 Rules of Procedure of the ESAC Page 18 of 18