Background
The Decision 2008/721/EC establishing the Scientific Risk Assessment Advisory Structure was adopted by the Commission on 5 September 2008. It replaces the Commission Decision 2004/210/EC setting up Committees in the field of consumer safety, public health and the environment.
Following an open call for expressions of interest, the Commission appointed the members of the Scientific Committees (SCCS, SCHER, and SCENIHR) and those of the Pool of Scientific Advisors on the basis of their expertise in one or more fields of competence which are set out in Annex I of Decision 2008/721/EC. Members are well-established scientists with more than 10 years of professional experience and multi-disciplinary accomplishments.
The Committees have adopted common rules of procedure that address in particular organisational and practical aspects including coordination between Scientific Committees, decision procedures, roles and obligations of the various parties involved and relations with third parties. They shall ensure that the Scientific Committees perform their tasks in compliance with the principles of excellence, independence, transparency, and confidentiality as well as risk assessment principles.
Composition
The SCCS, the SCHER and the SCENIHR each consist of a maximum of 17 members and may associate, at their own initiative, up to 5 scientific advisors from the Pool to contribute to a committee's work on specific issues. The associated members participate in the activities and deliberations on a given subject and have the same functions, responsibilities, and rights as the members of the Committee. The Commission may also ask members of the Pool of Scientific Advisors to replace on a permanent basis members of the Scientific Committees who resign or whose membership is terminated. In addition, members of the Pool may be included in the activities of different working groups, in the provision of rapid advice requested by the Commission, or in thematic workshops/scientific meetings. Members are appointed to the Scientific Committees for a term of three years and may not serve more than three consecutive terms. They remain in office until they are replaced or their appointments are renewed. Scientific advisors are appointed to the Pool for a period of five years and their appointment may be renewed.
Meetings
The Scientific Committees meet in plenary sessions between four to six times per year. Working Groups may be established by the Committees to undertake specific tasks related to the mandate provided by the Commission, such as preparing a draft opinion. They meet on a regular basis
The working language of the Scientific Committees and their Working Groups is English.
Tasks
The Scientific Committees usually work upon requests from Commission services. The Commission requests opinions in cases laid down by Community law (e.g. Cosmetics Directive (76/768/EEC), Toy Safety Directive (2009/48/EC)) and may request an opinion from the Committees on questions relevant to consumer safety, public health and the environment that are not falling within the mandate of other Community bodies. The task of the Committees is confined to scientific risk assessment.
The Commission may also request the Scientific Committees to provide rapid advice on the state of scientific knowledge concerning specific risks in case of urgent needs. It may invite a Scientific Committee to identify research needs and assess research results in relation to the subject areas covered by its fields of competence. Upon request or in agreement with the Commission, the Committees may also initiate and participate in relevant thematic workshops and networks with other Community bodies or scientific organizations.
The Scientific Committees shall draw the Commission’s attention to specific or emerging problems falling within their remit, which they consider may pose an actual or potential risk to consumer safety, public health or the environment, by adopting and addressing to the Commission memoranda or position statements. The Commission may decide to publish such memoranda and statements and shall determine the action to be taken including, if appropriate, a request for a scientific opinion on the matter.
Process
Following discussion between Commission services and the Secretariat, a draft request ('mandate') will be submitted to the Scientific Committee. This mandate describes the terms of reference, the community interest, the scientific background and, where appropriate, a deadline. The terms of reference are confined to scientific risk assessment. The Scientific Committee may require clarification and additional information from the Commission. Mandates are published as soon as possible on the Scientific Committee website. A public consultation on the mandate may be held in some cases which may lead to a change in the wording.
When a Scientific Committees receives a request for scientific advice from Commission services, it usually establishes a Working Group to support it in the elaboration of its opinion in response to the mandate.
The tasks of the WG are focussed in particular on reviewing and evaluating the scientific evidence and on drafting an opinion within a certain period in order to respond to the questions asked by the Commission. When doing so, the WG is asked to endeavour to reach a consensus on the scientific data that forms the basis of the opinion delivered. In the absence of a consensus, the position of the Working Group is the one approved by a simple majority of its Members. Nevertheless, the Chair of the Working Group and the Rapporteur will inform the Committee of all the positions expressed. The Working Group reports to the Scientific Committee to whose work it contributes and provides it with the reports or draft opinions as requested by the Committee. The final decision on a document lies with the Committee who decides on an opinion using a majority vote. However, the Committee usually consults the WG when proposing major changes to a document. A minority view on the opinion can only be expressed by members of the Committee.
During the course of preparing the draft opinion, it may be decided to issue a call for information to enable the submission and collection of all relevant scientific information.
In addition, the Scientific Committees and the Commission may decide to submit an approved version of the opinion (in form of a 'pre-consultation opinion') to a public consultation. The objective of such a consultation is to gather specific scientific comments and suggestions on the opinion, and obtain additional relevant scientific information regarding the questions addressed, in order to allow the Scientific Committees to focus on issues which need to be further analysed. This consultation process does not deal with policy or risk management needs and measures.
Following the public consultation, the Working Group, supported by the Secretariat, assesses the contributions received and proposes modifications to the opinion before proposing it for final adoption to the Scientific Committee, which will take its final decision either at a plenary session or by written procedure. An explanatory document reporting on the results of the public consultation is normally published together with the final opinion. In addition, a short chapter summarizing the outcome of the consultation is added to the final opinion.
Occasionally, the Committees and the Commission may decide to organize technical or public scientific hearings with stakeholders to obtain additional technical or scientific information or specific comments, suggestions, explanations or contributions on the scientific basis of a particular opinion. Under specific circumstances a technical hearing may be scheduled during the process of drafting the opinion while a public hearing is usually scheduled during the public consultation procedure to complement that process.
Involving stakeholders
There are several ways in which third parties may contribute to the work of the Scientific Committees can contribute to the work of the Scientific Committees. These are described in detail in chapter VIII and Annex IV of the Rules of Procedure.
Stakeholders may submit motivated and documented suggestions for new topics for the Scientific Committees and may, in certain circumstances make comments on working mandates. Furthermore, the Scientific Committees may require additional information from stakeholders for the completion of a scientific opinion. This may involve targeted calls for the submission of information, invited face-to-face meetings, consultations, and hearings. When an opinion has been prepared based on information submitted by an applicant in response to specific regulatory requirements, it may be published for comments by applicants, national authorities and other interested parties for a period of four weeks after publication. The intent of this commenting period is for applicants and other interested parties to provide limited additional perspective and/or clarification on the evaluation, interpretation, and incorporation of the submitted specific data package in the opinion. The comments are considered by the Scientific Committee in the final adoption process.
The opinions of the Scientific Committees on a particular subject will be considered closed and not subject to revision for a period of 3 years.
In addition to these activities, Commission services occasionally organize meetings, conferences and workshops with stakeholders
Principles
The Scientific Committees should perform their tasks in compliance with the principles of excellence, independence, transparency, and confidentiality. Chapter 4, Articles 15-17 of the Decision and chapters III – VII as well as Annex V of the Rules of Procedures provides further guidance on how the Scientific Committees should comply with these principles and describe the procedures in place to ensure their implementation.
Excellence, Independance, Transparency, Confidentiality
Excellence
The scientific advice delivered must represent the best information and guidance that science can provide at the time of adoption of the opinion under the conditions and deadlines imposed. It shall be based on the best data, scientific knowledge and methodology available at the time of preparation of an opinion.
The principle of excellence refers to the performance and outcome of the entire process. It refers in particular to the intrinsic scientific quality of the opinion, its adequacy in relation to the aims of the consultation, its clarity, completeness and transparency. It also refers to the effective communication of the contents and conclusions of the opinions and the actual and perceived credibility of the process.
Independence
The scientific advice delivered by the Committees must not be influenced by any consideration other than the scientific assessment of the risks in question. This principle implies in particular the independence from any external economic or political interests, but also from bias related to political, economic, social, philosophical, ethical, or any other non-scientific considerations. It refers to the organisation and results of the process, including the independence criteria, conditions and arrangements for the participation of Members, Advisors and Experts. The Members of the Scientific Committees, associated members, other scientific advisors of the Pool and the external experts are nominated in a personal capacity. They may not delegate their responsibilities to any other person. When participating in Working Groups they undertake to act independently of any external influence. For that purpose they make a declaration of commitment to act in the public interest and a declaration of interests indicating either the absence or existence of any direct or indirect interest which might be considered prejudicial to their independence. These declarations are made in writing.
Members of the Scientific Committees and scientific advisors associated to a Committee make written annual declarations of interests. Scientific Advisors and External Experts make a written specific declaration of interest when accepting to participate in any of the activities of the Advisory Structure. Members, Advisors and External Experts are under a continuing duty to declare any activity, situation, circumstance or other fact potentially involving a direct or indirect interest, in order to allow the Scientific Committees and/or the Commission to identify those interests which might be considered prejudicial to their independence. Therefore, Members, Scientific Advisors and External Experts participating in meetings of the Scientific Committees or in a Working Group or in any other activity of the Advisory Structure declare orally at each meeting any specific interest which might be considered as prejudicial to their independence in relation to the items on the agenda.
Annual declarations of interests are published on the website of the Committee. They must be completed or updated timely with any relevant additional or new information. Specific declarations will be published on the SC-webpage once an opinion has been published.
Members will discuss all new written and oral declarations at plenary meetings. The Committee’s discussion on the matter including conclusions and decisions taken, as well as their rationale is recorded in the meeting minutes. Any Member, Advisor or External Expert who, in accordance with their declaration or in the opinion of the Scientific Committee or the Working Group concerned, or the Commission, may not be able to act independently, is excluded from the activities considered or may only be allowed to participate to the extent and in a way compatible with the objective to preserve the process from any undue influence. In such a case, the Member, Advisor or Expert may not act as Rapporteur or as Chair in relation to the specific matter and may not participate in decision making. The extent of the participation in the Committee’s work of the individual concerned is decided by the Chair in consultation with the Members of the Committee or Working Group concerned and in agreement with the Commission within the framework of the Rules of Procedure. Measures may include the physical withdrawal from the meeting for the point under discussion, or participation limited to the provision of factual information.
However, it should be noted that high quality of scientific expertise is by nature based on prior experience. Therefore having an interest does not necessarily mean having a conflict of interest. The assessment of the declarations and the decision whether any of the interests declared might be considered prejudicial to the independence of the expert is taken by the SCs and Commission services. For the sake of transparency experts are asked to be as detailed and comprehensive as possible when declaring their interests and to consult the guidance document on declaring interests (see Annex II of the Rules of Procedure).
Transparency
The meaning of the scientific advice, the way conclusions were drawn, the limits of their validity and the relevant uncertainties must be clear and understandable for users, relevant stakeholders and the public. Equally, the organisation and process leading to the scientific advice, as well as their rationale, must be presented in a clear and understandable manner. Openness, dialogue, and collaboration with other bodies and third parties should also contribute to transparency.
The activities of the Scientific Committees shall be carried out with a high level of transparency. The following documents are published:
- The names of the members of the Scientific Committees as well as of the associated scientific advisors from the Pool, together with a brief curriculum vitae;
- the declarations of commitment, confidentiality and annual declarations of interests of the members of the Scientific Committees,
- the mandates for opinions
- draft agendas and minutes of the meetings of the Scientific Committees and the Inter-Committee Coordination Group
- minutes of meetings of working groups including the agenda
- final opinions and pre-consultation opinions published for public consultation (including the minority opinions and the names of the participants in the working groups that contributed to the opinion concerned; minority opinions shall be attributed to the members or advisors concerned)
- rapid advice adopted by the Scientific Committees
- the declarations of commitment, confidentiality and specific declarations of interest of scientific advisors and of external experts that participated in a working group, once the work has been concluded
- stakeholder dialogue activities (consultations on mandates, calls for information, calls for Experts, calls for hearings, public consultations on pre-consultation opinions etc.)
- Scientific Committee reports clarifying contentious issues as a result of a substantive divergence over scientific issues with other Community bodies (Art. 14(3) of Commission Decision 2008/721/EC);
- The common Rules of Procedures of the Scientific Committees.
Confidentiality
The members of the Scientific Committees, scientific advisors, external experts, and trainees may not divulge information acquired as a result of the work of the Scientific Committees, thematic workshops, working groups or other activities related to the application of this Decision, when they are informed that it is confidential. This will include, in particular, documents provided by third parties concerning sensitive industrial and commercial matters, and/or for which confidentiality has been requested and agreed by the Commission in accordance with the applicable provisions.
All participants and observers of the work of the Committees are to respect the confidentiality during the preparation of the opinion. Members, Advisors and External Experts make a written declaration of confidentiality (see Annex III). The obligation not to disclose confidential information continues to apply even after the participation of Members, Advisors and External Experts in the work of the Scientific Committees has ceased.
Throughout the process of preparing the draft opinion, membership in the WG is confidential.
With the exception of minority opinions referred to in Article 16 of Decision 2008/721/EC, individual views, whether expressed orally or in writing by Members, Associated Members and External Experts during deliberations within the Scientific Committee or a Working Group shall be confidential.
Names of Members, Advisors and External Experts appointed to Working Groups as well as their declarations of interest are published after the adoption of an opinion to which they have contributed. Nevertheless, their names may be disclosed earlier if necessary for their participation in hearings or other public events.
Availability of preparatory and draft working documents are restricted, on a need-to-know basis, to Members, Advisors, External Experts, the Commission’s Secretariat and representatives of the Commission’s services with competence for a specific question. They may not be given to third parties unless a different decision is taken in specific cases by the Scientific Committee concerned in agreement with the Commission, in view of a specific need to involve or inform urgently a third party as part of the process to complete the relevant work.
Collaboration with other bodies
The Scientific Committees assist the Commission and contribute to identifying at an early stage needs and possibilities for coordination of work and collaboration as well as potential or actual divergences in scientific opinions with other relevant Community, national or international bodies carrying out similar tasks, on general or specific risk assessment issues. They assist the Commission in avoiding, resolving, or clarifying divergent opinions and in establishing and maintaining collaboration relationships with such bodies.
In particular, the Scientific Committees assist the Commission on scientific technical matters requiring co-ordination and co-operation with other Community bodies charged with risk assessment, notably with the European Food Safety Authority (EFSA), the European Chemicals Agency (ECHA), the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA).
The Commission may take the initiative to request and organise joint work of the Scientific Committees with Community, national or international bodies carrying out similar tasks. It may in particular request the Scientific Committees to produce joint opinions with other Community bodies, upon agreement with such bodies. In such a case, the relevant mandate submitted by the Secretariat shall specify the sharing of tasks and responsibilities and the arrangements for the organisation of the work and adoption of the joint opinion.
In order to ensure that this co-operation is effective, the Commission may organise meetings of the Chairs of the Scientific Committees and the Chairs of other Community risk assessment bodies. Furthermore, the Scientific Committees may ask for the assistance of Members of the Scientific Committees or Panels of other Community bodies as External Experts if the question submitted has a bearing on the field of competence of one or more of the Scientific Committees and overlaps with the competence of other Community risk assessment bodies.
Where a substantive divergence over scientific issues has been identified and the body in question is a Community body, the Scientific Committee concerned shall, on the request of the Commission, cooperate with the body concerned with a view to either resolving the divergence or presenting a joint document to the Commission clarifying the contentious scientific issues and identifying the relevant uncertainties in the data. This document shall be made public.