02008D0721 — EN — 05.06.2010 — 002.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
COMMISSION DECISION of ►C1 5 September 2008 ◄ setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment and repealing Decision 2004/210/EC (Text with EEA relevance) (OJ L 241 10.9.2008, p. 21) |
Amended by:
|
|
Official Journal |
||
No |
page |
date |
||
L 196 |
61 |
28.7.2009 |
||
L 138 |
24 |
4.6.2010 |
Corrected by:
COMMISSION DECISION
of ►C1 5 September 2008 ◄
setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment and repealing Decision 2004/210/EC
(Text with EEA relevance)
(2008/721/EC)
CHAPTER 1
GENERAL PROVISIONS
Article 1
The advisory structure and its fields of competence
An advisory structure on scientific risk assessment in the areas of consumer safety, public health and the environment is hereby established. This structure includes:
the Scientific Committee on Consumer Safety (hereinafter SCCS);
the Scientific Committee on Health and Environmental Risks (hereinafter SCHER);
the Scientific Committee on Emerging and Newly Identified Health Risks (hereinafter SCENIHR);
a Pool of Scientific Advisors on Risk Assessment (hereinafter the Pool), which will support the activities of the Scientific Committees in accordance with the relevant provisions of this Decision.
Article 2
Mission
The Commission may also request an opinion from the Committees on questions:
of particular relevance to consumer safety, public health and the environment; and
not falling within the mandate of other Community bodies.
These workshops may involve, in addition to members of the Committees, scientific advisors from the Pool and external experts, including experts from Community, national or international bodies carrying out similar tasks, as appropriate.
These workshops shall be organised by the Secretariat of the Scientific Committees. The Secretariat shall define and ensure, where appropriate, the dissemination of the reports, position papers or conclusions resulting from the workshops.
CHAPTER 2
CONSTITUTION OF THE SCIENTIFIC COMMITTEES AND OF THE POOL
Article 3
Appointment of the members of the Scientific Committees
The members of each Scientific Committee shall be experts in one or more of the fields of competence of that Committee and shall collectively cover the widest possible range of disciplines.
Article 4
Establishment of the Pool
Article 5
Terms of office
In order to safeguard the continuity of the expertise, the Commission may, in exceptional circumstances, prolong the terms of office of the members of a Scientific Committee for a period not exceeding 18 months.
Members who have just completed three consecutive terms of office in a Scientific Committee shall be eligible for membership of another Scientific Committee.
CHAPTER 3
FUNCTIONING OF THE ADVISORY STRUCTURE
Article 6
Resort to the support of the Pool
Article 7
Working groups
Article 8
Participation of trainees
In agreement with the Commission and in accordance with the rules of procedure referred to in Article 12, the Scientific Committees may admit trainees to attend their meetings, with a view to contribute to capacity building in the area of risk assessment.
Article 9
Special requirements
Article 10
Election of the Chairs and Vice-Chairs
Article 11
Coordination of the Scientific Committees
An Inter-Committee Coordination Group (ICCG) composed of the Chairs and Vice-Chairs of the Scientific Committees shall ensure the coordination of the three Scientific Committees in accordance with the rules of procedures referred to in Article 12.
Article 12
Rules of procedures
Article 13
Voting rules
Article 14
Diverging opinions, coordination and collaboration with other Community, national or international bodies
The Scientific Committees shall assist the Commission and contribute to identifying at an early stage:
needs and possibilities for coordination of work and collaboration;
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 shall assist the Commission in avoiding, resolving or clarifying divergent opinions and in establishing and maintaining collaboration relationships with such bodies.
CHAPTER 4
PRINCIPLES
Article 15
Independence
For that purpose they shall 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 shall be made in writing. Members of the Scientific Committees and scientific advisors from the Pool shall make annual declarations.
Article 16
Transparency
The activities of the Scientific Committees shall be carried out with a high level of transparency. The Commission shall in particular make available to the public on its website, without undue delay:
the request for opinions addressed to the Scientific Committees;
agendas and minutes of the meetings of the Scientific Committees, Inter-Committee Coordination Group and working groups;
the scientific opinions, and rapid advice adopted by the Scientific Committees, 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;
the common rules of procedures of the Scientific Committees;
the names of the members of the Scientific Committees as well as of the scientific advisors from the Pool, together with a brief curriculum vitae of each member and advisor;
the declarations of interests of the members of the Scientific Committees, of the scientific advisors from the Pool and of the external experts that participated in a working group.
Article 17
Confidentiality
The members of the Scientific Committees, scientific advisors, external experts and trainees shall 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.
CHAPTER 5
FINAL PROVISIONS
Article 18
Secretariat of the Commission’s Scientific Committees
Article 19
Reimbursements and indemnities
Members of the Scientific Committees, scientific advisors from the Pool and external experts shall be entitled to an indemnity for their participation, in person or from a distance by electronic means, in the meetings of the committees, thematic workshops, working groups and other meetings and events organised by the Commission, and for serving as Rapporteur on a specific question, as provided for in Annex III.
Reimbursement of travel and subsistence costs shall be paid by the Commission.
Article 20
Replacement of the Scientific Committees
The Scientific Committees established by Article 1(1) of this Decision shall replace the existing Scientific Committees established by Decision 2004/210/EC as follows:
the Scientific Committee on Consumer Safety shall replace the Scientific Committee on Consumer Products;
the Scientific Committee on the Health and Environmental Risks shall replace the Committee of the same name;
the Scientific Committee on Emerging and Newly Identified Health Risks shall replace the Scientific Committee of the same name.
Article 21
Repeals
However, the three Committees established by that decision shall remain in office until the Scientific Committees established by this Decision take office.
ANNEX I
FIELD OF COMPETENCE
1. Scientific Committee on Consumer Safety
It shall provide opinions on questions concerning all types of health and safety risks (notably chemical, biological, mechanical and other physical risks) of non-food consumer products (for example: cosmetic products and their ingredients, toys, textiles, clothing, personal care and household products such as detergents, etc.) and services (for example: tattooing, artificial sun tanning, etc.).
2. Scientific Committee on Health and Environmental Risks
It shall provide opinions on health and environmental risks related to pollutants in the environmental media and other biological and physical factors or changing physical conditions which may have a negative impact on health and the environment, for example in relation to air quality, waters, waste and soils, as well as on life cycle environmental assessment. It shall also address health and safety issues related to the toxicity and eco-toxicity of biocides.
Without prejudice to the competences conferred on the European Chemical Agency (ECHA), Scientific Committee on Consumer Safety (SCCS) and other European risk assessment agencies, it may also be invited by the Commission to address, notably in collaboration with other European agencies and in particular ECHA, questions relating to examination of the toxicity and eco-toxicity of chemical, biochemical and biological compounds whose use may have harmful consequences for human health and the environment. In addition, the Committee will address questions relating to methodological aspect of the assessment of health and environmental risks of chemicals, including mixtures of chemicals, as necessary for providing sound and consistent advice in its own areas of competence as well as in order to contribute to the relevant issues in close cooperation with other European agencies.
3. The Scientific Committee on Emerging and Newly Identified Health Risks
It shall provide opinions on questions concerning emerging or newly identified health and environmental risks and on broad, complex or multidisciplinary issues requiring a comprehensive assessment of risks to consumer safety or public health and related issues not covered by other Community risk assessment bodies.
Examples of potential areas of activity include potential risks associated with interaction of risk factors, synergic effects, cumulative effects, antimicrobial resistance, new technologies such as nanotechnologies, medical devices including those incorporating substances of animal and/or human origin, tissue engineering, blood products, fertility reduction, cancer of endocrine organs, physical hazards such as noise and electromagnetic fields (from mobile phones, transmitters and electronically controlled home environments), and methodologies for assessing new risks. It may also be invited to address risks related to public health determinants and non-transmissible diseases.
ANNEX II
RULES OF PROCEDURES
The common rules of procedures to be adopted by the Scientific Committees in accordance with Article 12 shall cover in particular the following subjects:
1. coordination between the Scientific Committees
(a) the designation of the Scientific Committee responsible on request for scientific opinions which do not fall within the fields of competence of a single Scientific Committee or which need to be considered by more than one Committee;
(b) the adoption of joint opinions, rapid advice, memoranda and/or position statements;
(c) the procedures for ensuring coordination between the Scientific Committees including matters relating to harmonisation of risk assessment and the functioning of the Inter-Committee Coordination Group;
2. decision procedures within the Committees
(a) the election of the Chair and Vice-Chairs of the Scientific Committees;
(b) the procedures for the adoption of opinions:
(c) the procedure for the provision of rapid advice when so requested by the Commission in accordance with Article 2(3); this procedure shall ensure the quality and appropriate endorsement by the Committee of the advice;
(d) the adoption of memoranda and position papers to draw the attention of the Commission to specific or emerging problems;
3. organisation of the scientific works
(a) the creation and organisation of the working groups of the Scientific Committees, including joint working groups;
(b) the association of scientific advisors from the Pool to the activities of the Committees and the involvement of external experts;
(c) the appointment of Rapporteurs and the description of their tasks in relation to the preparation of draft opinions for the Scientific Committees;
(d) the format and content of scientific opinions and procedures for ensuring and improving their coherence as well as the editing standards;
(e) the organisation of, and participation in, meetings, thematic workshops, and networks;
(f) the association of trainees;
4. obligations of the members of the Committee, the associated and other scientific advisors from the Pool, external experts and for the trainees
(a) the participation criteria and the conditions under which membership of the Committee shall expire;
(b) the implementation of the confidentiality requirements laid down in Article 17;
(c) the responsibilities and obligations of members, associated and other scientific advisors from the Pool and external experts in relation to their contacts with petitioners, special interest groups and other stakeholders;
(d) the conditions and the procedure under which a member of a Committee, an associated or other scientific advisor or an external expert should be excluded from the deliberations and/or the vote on a particular subject in the Committee or in a working group, where there are reasonable doubts on his independence;
5. relations with third parties
(a) procedures for identifying, resolving or clarifying diverging opinions with Community, national and international bodies carrying out similar tasks, including information exchange and the organisation of joint meetings;
(b) representation of a Scientific Committee in external activities, notably in relation to other Community or international bodies engaged in similar activities;
(c) the organisation of the stakeholder dialogue procedure, in particular the organisation of hearings with industry or other special interest groups or other stakeholders;
(d) the publication of scientific opinions and other documents.
ANNEX III
INDEMNITIES
1. Members of the Scientific Committees, scientific advisors from the Pool and external experts shall be entitled to an indemnity for their participation in the meetings of the committees, thematic workshops, working groups and other meetings and events organised by the Commission as follows:
in the case of participation in person, EUR 385 for each day in which they were present;
in the case of participation from distance, EUR 100 for every begun hour of attendance, with a ceiling of:
EUR 385 for attendance over a morning and an afternoon; and
EUR 195 for attendance over a morning or an afternoon;
2. Members of the Scientific Committees, scientific advisors from the Pool and external experts shall be entitled to an indemnity for acting as Rapporteur as follows:
the indemnity shall be modulated, depending on the workload related to the complexity of the matter, the length of the period needed to complete the opinion, the amount and accessibility of data and scientific literature and information to be collected and processed and the extent and complexity of public and stakeholder consultations and contacts with other bodies, in light of the following indicative criteria:
Amount |
Indicative criteria |
EUR 385 |
— Simple and routine issue — Opinion based on examination of a dossier, with limited data search and limited literature examination — No public consultation — No more than five months between first and last meeting |
EUR 770 |
— Complex issue — Opinion based on significant data and literature search and examination — Stakeholder and/or public consultation with limited feedback examination workload — From five to nine months between the first and the last meeting |
EUR 1 155 |
— Very complex issue — Need for very extensive data and literature search and analysis — Extensive and complex consultations with stakeholder, the public and other scientific bodies, with important feedback to be examined — More than nine months between the first and the last meeting |
in each specific case, on the basis of the criteria mentioned in point (a), the Commission shall indicate in the request for an opinion which of the amounts for the indemnity of the Rapporteur applies. The choice of the applicable amount may be modified by the Commission during the preparatory work for the requested opinion if that is justified by unforeseen changes in relation to the relevant criteria.
( 1 ) OJ L 66, 4.3.2004, p. 45.
( 2 ) OJ L 114, 1.5.2007, p. 14.
( 3 ) OJ L 396, 30.12.2006, p. 1. Corrected by OJ L 136, 29.5.2007, p. 3.
( 4 ) OJ L 287, 1.11.2007, p. 25.
( 5 ) COM(2002) 713 final of 11 December 2002.
( 6 ) OJ L 8, 12.1.2001, p. 1.
( 7 ) OJ L 145, 31.5.2001, p. 43.