2004/210/EC: Commission Decision of 3 March 2004 setting up Scientific Committees in the field of consumer safety, public health and the environment (Text with EEA relevance)
Date: 2004-03-03
Institutions: European Commission
Subjects: consumer protection, environmental protection, public health, scientific committee (EU)

4.3.2004

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Official Journal of the European Union

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COMMISSION DECISION

of 3 March 2004

setting up Scientific Committees in the field of consumer safety, public health and the
environment

(Text with EEA relevance)

(2004/210/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Com-
munity, and in particular Articles 152 and 153 thereof,

Whereas:

(1)

(2)

(3)

(4)

The Scientific Committees were established by Commis-
sion Decision 97/404/EC of 10 June 1997 setting up a
Scientific Steering Committee (1) and by Commission
Decision 97/579/EC of 23 July 1997 setting up Scien-
tific Committees in the field of consumer health and
food safety (2).

The responsibilities of the Scientific Steering Committee
(SSC) in relation to scientific advice on bovine spongi-
form encephalophathy and transmissible spongiform
encephalopathies have been transferred to the European
Food Safety Authority (EFSA) established by 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 the
procedures in matters of food safety (3).

Also the responsibilities of five of the eight Scientific
Committees established by Decision 97/579/EC have
been transferred to EFSA namely the responsibilities of
the Scientific
the Scientific Committee on Food,
Committee
Scientific
the
on Animal Nutrition,
Committee on Animal Health and Animal Welfare the
Scientific Committee on Veterinary Measures relating to
Public Health, and of the Scientific Committee on Plants.

The terms of office of the members of the remaining
three Scientific Committees established by Commission
Decision 97/579/EC, namely the Scientific Committees
on Cosmetic Products and Non-food Products intended
for Consumers, the Scientific Committee on Medicinal
Products
and the Scientific
Committee on Toxicity, Ecotoxicity and the Environment

and Medical Devices

(1) OJ L 169, 27.6.1997, p. 85; Decision as amended by Decision

2000/443/EC (OJ L 179, 18.7.2000, p. 13).

(2) OJ L 237, 28.8.1997, p. 18; Decision as amended by Decision

2000/443/EC.

(3) OJ L 31, 1.2.2002, p. 1; Regulation as amended by Regulation (EC)

No 1642/2003 (OJ L 245, 29.9.2003, p. 4).

(5)

(6)

(7)

(8)

(9)

have come to an end. Members of those committees
remain in office until they are replaced or their appoint-
ments are renewed.

It is therefore necessary to replace Decision 97/404/EC
and Decision 97/579/EC and to repeal these acts.

Sound and timely scientific advice is an essential require-
ment for Commission proposals, decisions and policy
relating to consumer safety, public health and the envir-
onment.

The advice of
the Scientific Committees on matters
relating to consumer safety, public health and the envir-
onment must be based on the principles of excellence,
independence and impartiality, and transparency, as
developed in the Commission Communication on ‘The
collection and use of expertise by the Commission: prin-
ciples and guidelines.
Improving the knowledge for
better policies’ (4).

It is essential that the Scientific Committees make best
use of external expertise in the EU and beyond as may
be necessary for a specific question.

It is timely to reorganise the Scientific Committee advi-
sory structure in the light of operational experience, the
establishment of the EFSA and the Commission's future
needs for independent scientific advice. Such a structure
must provide the flexibility to allow it to advise the
Commission on matters falling under established areas
of competence as well as on emerging and newly identi-
fied health risks and matters not within the competence
of other Community risk assessment bodies.

(10)

The need for independent scientific advice both in estab-
lished and new areas of Community responsibilities
the
falling within the
Scientific
competence
Committee on Cosmetic
and Non-food
Products intended for Consumers and the Scientific
Committee on Toxicity, Ecotoxicity and the Environment
is likely to continue to increase.

of
Products

(4) COM (2002) 713 final of 11 December 2002 on ‘The collection
and use of expertise by the Commission: principles and guidelines.
Improving the knowledge for better policies’.

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(11)

(12)

The number of requests for scientific advice from the
Scientific Committee on Medicinal Products and Medical
Devices are too few to justify its continuation as a sepa-
rate Committee. However,
the potential
importance of this area and in particular of medical
devices, it is necessary to retain the capacity to provide
scientific
through an appropriate Scientific
Committee.

in view of

advice

In order to strengthen their scientific coherence, syner-
gisms and a multi-disciplinary approach and at the same
time minimise overlapping responsibility, it is necessary
to redefine the fields of competence of the Scientific
Committees and to ensure systematic and structured
coordination.

(13)

It is important that the Commission can take a proactive
approach to the early assessment of emerging and other
newly identified risks,

HAS DECIDED AS FOLLOWS:

Article 1

Scientific Committee advisory structure and fields of
competence

The following Scientific Committees are hereby estab-

1.
lished:

(a) the Scientific Committee on Consumer Products (herein-

after SCCP).

(b) the Scientific Committee on Health and Environmental

Risks (hereinafter SCHER).

(c) the Scientific Committee on Emerging and Newly Identified

Health Risks (hereinafter SCENIHR).

2.
The fields of competence of the Scientific Committees
shall be as set out in Annex I, without prejudice to the compe-
tence conferred by Community legislation to other Community
bodies undertaking risk assessment, such as the European Food
Safety Authority and the European Agency for the Evaluation
of Medicinal Products.

Article 2

Mission

1.
The Commission shall request a scientific opinion from
the Scientific Committees in the cases laid down by Com-
munity law. The Commission may also request an opinion
from the Committees on questions:

(a) of particular relevance to consumer safety, public health

and the environment; and

(b) not falling within the mandate of other Community bodies.

Requests for a scientific opinion on questions which do
2.
not fall within the fields of competence of a single scientific
committee or which need to be considered by more than one
Committee, shall be addressed in accordance with the rules of
procedures set out in Article 10(2)(c). The same shall apply to
needs for clarification of requests for scientific opinions in
accordance with the rules of procedure set out
in Article
10(2)(b).

The Commission may require the adoption of a scientific
3.
opinion from a Scientific Committee within a specified period.

The Scientific Committees shall draw the Commission's
4.
attention to a specific or emerging problem falling within their
remit, which they consider may pose an actual or potential risk
to consumer safety, public health or the environment. The
Commission shall determine the action to be taken including, if
appropriate, a request for a scientific opinion on the matter.

5.
Subject
require additional
completion of a scientific opinion.

to paragraph 3, a Scientific Committee may
the

information from stakeholders

for

A Scientific Committee may give a deadline for submitting the
required information to it. If the required information has not
been submitted within that deadline, the Committee may adopt
its opinion on the basis of the available information.

Article 3

Appointment of the members of the Scientific Commit-
tees and associated members

1.
The SCCP and the SCHER shall each consist of a
maximum of 19 members. They shall be appointed on the
basis of their expertise and consistent with this a geographical
distribution that reflects the diversity of scientific problems and
approaches in the Community. The Commission shall deter-
mine the number of members in each committee in accordance
with the requisite needs.

2.
The SCENIHR shall be composed of 13 members. They
shall be appointed on the basis of their broad expertise in the
application of risk assessment and, consistent with this, a
geographical distribution that reflects the diversity of scientific
problems and approaches in the Community.

For any specific question, the SCENIHR may enlist the support
of up to six associated members selected on the basis of their
expertise. Associated members shall have the same rights to
participate in the discussions and responsibilities as members.

3.
The members of each Scientific Committee shall be scien-
tific experts in one or more of the fields of competence of that
Committee and shall collectively cover the widest possible
range of disciplines.

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The Commission shall appoint the members of the Scien-
4.
tific Committees from a list of suitable candidates established
following publication in the Official
the European
Union and on the Commission website of a call for expressions
of interest.

Journal of

2. When it is found that a member does not participate to
the work of a Scientific Committees or wishes to resign, the
Commission may terminate the member's membership and
appoint a replacement from the reserve list provided for in
Article 4.

No member of a Scientific Committee may be appointed

5.
to more than one of the Committees set out in Article 1(1).

Article 8

Article 4

Constitution of a reserve list

Candidates found suitable for the position in a Scientific
1.
Committee but not appointed shall be invited to be included
on a reserve list. The reserve list may be used by:

(a) the Commission to identify suitable candidates to replace

members in accordance with Article 7(2);

(b) the SCENIHR to identify associated members having the

required expertise for specific questions;

(c) the Scientific Committees to identify external experts in

working groups;

Working groups and participation of external experts

In agreement with the Commission,

1.
the Scientific
Committees may invite specialised external experts that they
consider to have the relevant scientific knowledge and expertise
to contribute to their work.

2.
The Scientific Committees may create specific working
groups with clearly defined tasks. These working groups shall
be established in particular when there is a need for external
expertise to fulfil the mandate of the Committee. In such cases,
it shall draw on the expertise of those working groups when
adopting scientific opinions.

3.
The working groups shall be chaired by a member of the
Scientific Committee that convened them and shall report to it.

2.
Associated members shall be selected from the reserve list
or from lists established by other Community bodies following
open selection procedures designed to fulfil the requirements
for excellence and independence.

4. When a question is common to more than one Scientific
Committee, a common working group including members
from the Committees, associated members concerned and
external experts as necessary shall be set up.

Article 5

Election of the Chairs and Vice-chairs

Article 9

Reimbursements and indemnities

1.
Each Scientific Committee shall elect a Chair and two
Vice-Chairs from among their members. The election shall take
place by simple majority of the members which make up the
Committee. The term of office of the Chair and Vice-Chair shall
be three years, renewable.

2.
The procedure for the election of the Chair and Vice-
Chairs of the Scientific Committees shall be laid down in the
rules of procedures.

Members of the Scientific Committees, Associated Members
and the external experts shall be entitled to an indemnity for
their participation in the meetings of the Committees and for
serving as Rapporteur on a specific question, as provided for in
Annex II.

Reimbursement of travel and subsistence costs shall be paid by
the Commission.

Article 6

Coordination of the Scientific Committees

The Chairs shall assist the Commission on matters relating to
the coordination of the three Scientific Committees in accord-
ance with the rules of procedures referred to in Article
10(2)(d).

Article 7

Terms of office

1. Members shall be appointed to the Scientific Committees
for a term of three years, and may not serve for more than
three consecutive terms. They shall remain in office until they
are replaced or their appointments are renewed.

Members who have just completed three consecutive terms of
office in a Scientific Committee shall be eligible for member-
ship of another Scientific Committee.

Article 10

Rules of procedures

1.
The Scientific Committees shall adopt common rules of
procedure in consultation with the Commission. The rules of
procedure shall ensure that the Scientific Committees perform
their tasks in compliance with the principles of excellence,
independence and transparency, whilst having regard to legiti-
mate requests for commercial confidentiality.

2.

The rules of procedure shall cover in particular:

(a) the election of the Chair and Vice-Chairs of the Scientific

Committee;

(b) the procedures for:

(i) the coordination and allocation of questions,
(ii) the adoption of opinions under normal conditions, and
(iii) the adoption of opinions under an accelerated, written
procedure if the urgency of the matter requires such a
procedure;

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(c) the designation of the Scientific Committee responsible for
dealing with questions common to more than one Scientific
Committee;

(d) the procedures for ensuring coordination between the
Scientific Committees including matters relating to harmo-
nisation of risk assessment;

(e) the creation and organisation of the working groups of the

Scientific Committees;

(f) the involvement of external experts and, for the SCENIHR,

of associated members;

(g) the appointment of Rapporteurs and the description of
their tasks in relation to the preparation of draft opinions
for the Scientific Committees;

(h) the format and content of scientific opinions and proce-

dures for ensuring and improving their coherence;

(i) procedures for identifying, resolving or clarifying diverging
and international bodies
opinions with Community
carrying out similar tasks, including information exchange
and the organisation of joint meetings;

(j) the organisation of hearings with industry or other special

interest groups;

(k) the responsibilities and obligations of members, associated
members and external experts in relation to their contacts
with petitioners, special
interest groups and other stake-
holders;

(l) representation of a Scientific Committee in external activ-
ities, notably in relation to other Community or interna-
tional bodies engaged in overlapping activities.

Article 11

Voting rules

Each Scientific Committees shall act by a majority of
members.

its

Article 12

Adoption of scientific opinions

The Scientific Committees shall adopt
majority of the Members which make up the Committee.

their opinions by a

Article 13

Diverging opinions

1.
The Scientific Committees shall assist the Commission in
identifying at an early stage potential or actual divergence
between their scientific opinions and the scientific opinions of
Community and International bodies carrying out similar tasks.
They shall assist the Commission in avoiding, resolving or clari-
fying divergent opinions.

2. 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 docu-
ment to the Commission clarifying the contentious scientific
issues and identifying the relevant uncertainties in the data.
This document shall be made public.

Article 14

Independence

1.
The Members of the Scientific Committees and associated
members shall be nominated in a personal capacity. They shall
not delegate their responsibilities to another member or to a
third person.

the Scientific Committees and associated
2. Members of
members shall undertake to act independently of any external
influence.

For that purpose they shall make a declaration of commitment
to act in the public interest and a declaration of interests indi-
cating either the absence or existence of any interest which
might be considered prejudicial to their independence.

These declarations shall be made in writing and be publicly
available. Members of the Scientific Committees shall make
annual declarations.

the

Scientific Committees,

3. Members of
associated
members and the external experts participating in working
groups shall declare at each meeting any specific interest which
might be considered as prejudicial to their independence in
relation to the items on the agenda.

Article 15

Transparency

Request for opinions, agendas, minutes and opinions of
1.
the Scientific Committees shall be published without undue
delay and with regard to the need for commercial confidenti-
ality.

2. Minority opinions
shall always be included in the
opinions of the Scientific Committees and shall be attributed to
the members or associated members concerned.

The rules of procedures

3.
Commission's website.

shall be published on the

4.
The names of the members of the Scientific Committees
shall be published in the Official Journal of the European Union.
They shall also be made available on the Commission's website
together with a brief Curriculum vitae of each member.

The names of participants in the working groups shall be given
with the opinion to which they have contributed.

5.
The reserve list resulting from the call for expressions of
interest shall be published in the Official Journal of the European
Union. It shall also be made available on the Commission's
website.

Article 16

Confidentiality

The members of the Scientific Committees, associated members
and external experts shall not divulge information acquired as a
result of the work of the Scientific Committees, or one of the
working groups, when they are informed that it is confidential.

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Article 17

Secretariat of the Commission's Scientific Committees

The Scientific Committees and their working groups shall

1.
be convened by the Commission.

The Commission shall provide the scientific and adminis-
the Scientific Committees and their

2.
trative secretariat of
working groups.

The secretariat shall be responsible for providing scientific
3.
and administrative support necessary to facilitate the efficient
functioning of the Scientific Committees in compliance with
the rules of procedure, particularly in relation to the require-
ments for excellence, independence and transparency.

4.
The secretariat shall ensure the scientific and technical
coordination of the activities of the Scientific Committees and
where necessary coordination of their activities with those of
other Community and international bodies.

Article 18

Replacement of the Scientific Committees

The Scientific Committees established by Article 1(1) of this
Decision shall replace the existing Scientific Committees estab-
lished by Decision 97/579/EC as follows:

(a) the Scientific Committee on Consumer Products

shall
replace the Scientific Committee on Cosmetic Products and
Non-Food Products intended for Consumers;

(b) the Scientific Committee on the Health and Environmental
Risks shall replace the Scientific Committee on Toxicity,
Ecotoxicity and the Environment;

(c) the Scientific Committee on Emerging and Newly Identified
Health Risks shall replace the Scientific Committee on
Medicinal Products and Medical Devices.

Article 19

Repeals

1.

Decisions 97/404/EC and 97/579/EC are repealed.

However, the three Committees established by those decisions
shall remain in office until the Scientific Committees estab-
lished by this Decision take office.

2.
References to the repealed decisions shall be understood
as applicable to this Decision; references to the Committees
and sections established by the repealed decisions shall be
understood as applicable to the Committees established by this
Decision.

Done at Brussels, 3 March 2004.

For the Commission

David BYRNE

Member of the Commission

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ANNEX I

FIELD OF COMPETENCE

1. Scientific Committee on Consumer Products

It shall provide opinions on questions concerning the safety of consumer products (non-food products intended for
the consumer). In particular, it shall address questions in relation to the safety and allergenic properties of cosmetic
products and ingredients with respect to their impact on consumer health, toys, textiles, clothing, personal care
products, domestic products such as detergents and consumer services such as tattooing.

2. Scientific Committee on Health and Environmental Risks

It shall provide opinions on questions relating to examinations of the toxicity and ecotoxicity of chemical, biochem-
ical and biological compounds whose use may have a harmful consequences for human health and the environment.
In particular, it shall address questions in relation to new and existing chemicals, the restriction and marketing of
dangerous substances, biocides, waste, environmental contaminants, plastic and other materials used for water pipe-
work (e.g. new organics substances), drinking water, indoor and ambient air quality.

It shall address questions relating to human exposure to mixtures of chemicals, sensitisation and identification of
endocrine disrupters.

3. The Scientific Committee on Emerging and Newly Identified Health Risks

It shall provide opinions on questions concerning emerging or newly identified risks and on broad, complex or multi-
disciplinary 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.

ANNEX II

INDEMNITIES

Members of the Scientific Committees, Associated Members and the external experts shall be entitled to indemnities
related to their participation in the activities of the scientific committees as follows:

For participation at meetings:
— EUR 300 for each full day participation or EUR 150 for participation in a morning or afternoon meeting of a Scien-
tific Committee, a working group or at an external meeting attended in connection with the work of a Scientific
Committee.

For acting as Rapporteur for a question requiring not less than one day of preparation of a draft opinion and with the
prior written agreement of the Commission:
— EUR 300.
— Where fully justified and subject to budget availability, this sum may be exceptionally increased to EUR 600 for

questions which are particularly demanding in terms of work load.

For particularly complex questions of a multidisciplinary nature, more than one Rapporteur may be appointed.