Codex Alimentarius
Codex Alimentarius
C O D E X A L I M E N T A R I U S
ISSN 1020-8070
C
MY
CY
9 789251 057001
TC/M/A1100E/1/04.07/2500
Contents
CONTENTS
Introduction............................................................................................... 1
SECTION I
Statutes of the Codex Alimentarius Commission ..................................... 3
Rules of Procedure of the Codex Alimentarius Commission .................. 6
Procedures for the Elaboration of Codex Standards
and Related Texts ................................................................................... 19
General Principles of the Codex Alimentarius ....................................... 30
Guidelines on Cooperation between the Codex Alimentarius
Commission and International Intergovernmental Organizations
in the Elaboration of Standards and Related Texts................................. 31
Principles Concerning the Participation of International NGO’s
in the Work of the Codex Alimentarius Commission............................. 34
Definitions for the Purposes of the Codex Alimentarius ........................ 41
SECTION II
Guidelines for Codex Committees and Ad Hoc
Intergovernmental Task Forces .............................................................. 47
Guidelines to Host Governments.....................................................................47
Guidelines on the Conduct of Meetings ..........................................................53
Guidelines to Chairpersons..............................................................................56
Guidelines on Physical Working Groups ........................................................60
Guidelines on Electronic Working Groups .....................................................63
Criteria for the Establishment of Work Priorities ................................... 66
Criteria For The Prioritization Process Of Compounds
For Evaluation By JMPR.................................................................................67
iii
Contents
vi
Introduction
INTRODUCTION
1
Section I
SECTION I
Statutes
Rules of Procedure
Elaboration Procedures
General Principles
Guidelines on Cooperation between the Codex Alimentarius
Commission and International Intergovernmental Organizations in the
Elaboration of Standards and Related Texts
Principles Concerning the Participation of International Non-
Governmental Organizations in the Work of the Codex Alimentarius
Commission
Definitions
2
Statutes
ARTICLE 1
The Codex Alimentarius Commission shall, subject to Article 5 below, be
responsible for making proposals to, and shall be consulted by, the Directors-
General of the Food and Agriculture Organization (FAO) and the World Health
Organization (WHO) on all matters pertaining to the implementation of the Joint
FAO/WHO Food Standards Programme, the purpose of which is:
(a) protecting the health of the consumers and ensuring fair practices in
the food trade;
(b) promoting coordination of all food standards work undertaken by
international governmental and non governmental organizations;
(c) determining priorities and initiating and guiding the preparation of
draft standards through and with the aid of appropriate
organizations;
(d) finalizing standards elaborated under (c) above and publishing them
in a Codex Alimentarius either as regional or world wide standards,
together with international standards already finalized by other
bodies under (b) above, wherever this is practicable;
(e) amending published standards, as appropriate, in the light of
developments.
ARTICLE 2
Membership of the Commission is open to all Member Nations and Associate
Members of FAO and WHO which are interested in international food standards.
Membership shall comprise such of these nations as have notified the Director-
General of FAO or of WHO of their desire to be considered as Members.
ARTICLE 3
Any Member Nation or Associate Member of FAO or WHO which is not a
Member of the Commission but has a special interest in the work of the
Commission, may, upon request communicated to the Director-General of FAO
or WHO, as appropriate, attend sessions of the Commission and of its subsidiary
bodies and ad hoc meetings as observers.
ARTICLE 4
Nations which, while not Member Nations or Associate Members of FAO or
WHO, are members of the United Nations, may be invited on their request to
3
Section I
5
Rules of procedure
RULE I MEMBERSHIP
1. Membership of the Joint FAO/WHO Codex Alimentarius Commission,
hereinafter referred to as “the Commission”, is open to all Member Nations and
Associate Members of FAO and/or WHO.
2. Membership shall comprise such eligible nations as have notified the
Director-General of FAO or of WHO of their desire to be considered Members
of the Commission.
3. Membership shall also comprise regional economic integration
organizations members of either FAO or WHO that notify the Director-General
of FAO or WHO of their desire to be considered Members of the Commission.
4. Each Member of the Commission shall communicate to the Director-
General of FAO or of WHO the names of its representative and where possible
other members of its delegation before the opening of each session of the
Commission.
RULE II - MEMBER ORGANIZATIONS
1. A Member Organization shall exercise membership rights on an alternative
basis with its Member States that are Members of the Commission in the areas
of their respective competence.
2. A Member Organization shall have the right to participate in matters
within its competence in any meetings of the Commission or its subsidiary
bodies in which any of its Member States is entitled to participate. This is
without prejudice to the possibility for the Member States to develop or support
the position of the Member Organization in areas within its competence.
3. A Member Organization may exercise on matters within its competence, in
any meetings of the Commission or any subsidiary body of the Commission in
which it is entitled to participate in accordance with paragraph 2, a number of
votes equal to the number of its Member States which are entitled to vote in
such meetings and present at the time the vote is taken. Whenever a Member
Organization exercises its right to vote, its Member States shall not exercise
theirs, and conversely.
4. A Member Organization shall not be eligible for election or designation,
nor to hold office in the Commission or any subsidiary body. A Member
Organization shall not participate in voting for any elective places in the
Commission and its subsidiary bodies.
6
Rules of procedure
1
The word ‘decisions’ should be understood to mean both voting and
situations where a decision is taken by consensus.
2
The above is without prejudice to the question of whether or not the
views of the party not having the right to vote shall be reflected in the report of
the meeting. Where the views of the party not having the right to vote are
reflected in the report, the fact that they are the views of the party not having the
right to vote shall also be reflected in the report.
7
Rules of procedure
8
Rules of procedure
the Commission which constitute the region or group, that work for the Codex
Alimentarius in the countries concerned so requires.
2. Appointment of Coordinators shall be made exclusively on the proposal of
a majority of the Members of the Commission which constitute the region or
group of countries concerned. In principle, they shall be nominated at each
session of the relevant Coordinating Committee established under Rule
XI.1(b)(ii), and appointed at the following regular session of the Commission.
They shall hold office from the end of this session. Coordinators may be
reappointed for a second term. The Commission shall make such arrangements
as may be necessary in order to ensure continuity in the functions of the
Coordinators.
3. The functions of the Coordinators shall be:
(i) to assist and coordinate the work of the Codex Committees set up
under Rule XI.1(b)(i) in their region or group of countries in the
preparation of draft standards, guidelines and other
recommendations for submission to the Commission;
(ii) to assist the Executive Committee and the Commission, as
required, by advising them of the views of countries and
recognized regional intergovernmental and non-government
organizations in their respective regions on matters under
discussion or of interest.
RULE V EXECUTIVE COMMITTEE
1. The Executive Committee shall consist of the Chairperson and the Vice-
Chairpersons of the Commission, and the Coordinators appointed on the basis of
Rule IV together with seven further Members elected by the Commission at
regular sessions from among the Members of the Commission, one each coming
from the following geographic locations: Africa, Asia, Europe, Latin America
and the Caribbean, Near East, North America, South-West Pacific. Not more
than one delegate from any one country shall be a member of the Executive
Committee. Members elected on a geographic basis shall hold office from the
end of the session of the Commission at which they were elected until the end of
the second succeeding regular session and shall be eligible for re-election if they
have not served for more than two years in their current term, but after having
served two consecutive terms shall be ineligible to hold such office for the next
succeeding term.
2. The Executive Committee shall, between sessions of the Commission, act
on behalf of the Commission as its executive organ. In particular, the Executive
Committee may make proposals to the Commission regarding general
orientation, strategic planning, and programming of the work of the
9
Rules of procedure
Commission, study special problems and shall assist in the management of the
Commission’s programme of standards development, namely by conducting a
critical review of proposals to undertake work and monitoring the progress of
standards development.
3. The Executive Committee shall consider specific matters referred to it by
the Directors-General of FAO and WHO as well as the estimate of expenditure
for the Commission’s proposed programme of work as described in Rule XIII.1.
4. The Executive Committee may establish such sub-committees from
among its Members as it may deem necessary to enable it to exercise its
functions as effectively as possible. Such sub-committees should be limited in
numbers, carry out preparatory work and report to the Executive Committee.
The Executive Committee shall appoint one of the Vice-Chairpersons of the
Commission to serve as chairpersons of any such sub-committee. Consideration
should be given to an appropriate geographical balance in the membership of
sub-committees.
5. The Chairperson and Vice-Chairpersons of the Commission shall be
respectively the Chairperson and Vice-Chairpersons of the Executive
Committee.
6. Sessions of the Executive Committee may be convened as often as
necessary by the Directors-General of FAO and WHO, in consultation with the
Chairperson. The Executive Committee shall normally meet immediately prior
to each session of the Commission.
7. The Executive Committee shall report to the Commission.
RULE VI SESSIONS
1. The Commission shall in principle hold one regular session each year at
the Headquarters of either FAO or WHO. Additional sessions shall be held as
considered necessary by the Directors-General of FAO and WHO after
consultation with the Chairperson of the Executive Committee.
2. Sessions of the Commission shall be convened and the place of the
meeting shall be determined by the Directors-General of FAO and WHO after
consultation where appropriate, with the authorities of the host country.
3. Notice of the date and place of each session of the Commission shall be
communicated to all Members of the Commission at least two months before
the session.
4. Each Member of the Commission shall have one representative, who may
be accompanied by one or more alternates and advisers.
10
Rules of procedure
11
Rules of procedure
been adopted, the Commission may, by a two-thirds majority of the votes cast,
amend the Agenda by the deletion, addition or modification of any other item.
7. Documents to be submitted to the Commission at any session shall be
furnished by the Directors-General of FAO and WHO to all Members of the
Commission, to the other eligible Nations attending the session as observers and
to the non-member nations and international organizations invited as observers
thereto, in principle at least two months prior to the session at which they are to
be discussed.
RULE VIII VOTING AND PROCEDURES
1. Subject to the provisions of paragraph 3 of this Rule, each Member of the
Commission shall have one vote. An alternate or adviser shall not have the right
to vote except where substituting for the representative.
2. Except as otherwise provided in these rules, decisions of the Commission
shall be taken by a majority of the votes cast.
3. At the request of a majority of the Members of the Commission
constituting a given region or a group of countries that a standard be elaborated,
the standard concerned shall be elaborated as a standard primarily intended for
that region or group of countries. When a vote is taken on the elaboration,
amendment or adoption of a draft standard primarily intended for a region or
group of countries, only Members belonging to that region or group of countries
may take part in the voting. The adoption of the standard may, however, take
place only after submission of the draft text to all Members of the Commission
for comments. The provisions of this paragraph shall not prejudice the
elaboration or adoption of a corresponding standard with a different territorial
scope.
4. Subject to the provisions of paragraph 5 of this Rule and paragraph 2 of
Rule XII, any Member of the Commission may request a roll-call vote, in which
case the vote of each Member shall be recorded.
5. Elections shall be decided by secret ballot, except that, where the number
of candidates does not exceed the number of vacancies, the Chairperson may
submit to the Commission that the election be decided by clear general consent.
Any other matter shall be decided by secret ballot if the Commission so
determines.
6. Formal proposals relating to items of the Agenda and amendments thereto
shall be introduced in writing and handed to the Chairperson, who shall circulate
them to representatives of Members of the Commission.
12
Rules of procedure
7. The provisions of Rule XII of the General Rules of FAO shall apply
mutatis mutandis to all matters which are not specifically dealt with under Rule
VIII of the present Rules.
RULE IX OBSERVERS
1. Any Member Nation and any Associate Member of FAO or WHO which is
not a Member of the Commission but has a special interest in the work of the
Commission, may, upon request communicated to the Director-General of FAO
or WHO, attend sessions of the Commission and of its subsidiary bodies as an
observer. It may submit memoranda and participate without vote in the
discussion.
2. Nations which, while not Member Nations or Associate Members of FAO
or WHO, are Members of the United Nations, may, upon their request and
subject to the provisions relating to the granting of observer status to nations
adopted by the Conference of FAO and the World Health Assembly, be invited
to attend in an observer capacity sessions of the Commission and of its
subsidiary bodies. The status of nations invited to such sessions shall be
governed by the relevant provisions adopted by the Conference of FAO.
3. Any Member of the Commission may attend as an observer the sessions of
the subsidiary bodies and may submit memoranda and participate without vote
in the discussions.
4. Subject to the provisions of paragraphs 5 and 6 of this Rule, the Directors-
General of FAO or WHO may invite intergovernmental and international non-
governmental organizations to attend as observers sessions of the Commission
and of its subsidiary bodies.
5. Participation of intergovernmental organizations in the work of the
Commission and the relations between the Commission and such organizations
shall be governed by the relevant provisions of the Constitutions of FAO or
WHO, as well as by the applicable regulations of FAO or WHO on relations
with intergovernmental organizations; such relations shall be handled by the
Director-General of FAO or WHO, as appropriate.
6. Participation of international non-governmental organizations in the work
of the Commission and the relations between the Commission and such
organizations shall be governed by the relevant provisions of the Constitution of
FAO or WHO, as well as by applicable regulations of FAO or WHO on
relations with international non-governmental organizations. Such relations
shall be handled by the Director-General of FAO or WHO, as appropriate, on
the advice of the Executive Committee. The Commission shall develop and
keep under review principles and criteria concerning the participation of
13
Rules of procedure
14
Rules of procedure
16
Rules of procedure
17
Rules of procedure
18
Elaboration procedures
INTRODUCTION
The full procedure for the elaboration of Codex standards is as follows.
1. The Commission shall implement a unified approach in the area of
standards development by taking its decisions, based on a strategic planning
process (“standards management”) (See Part 1 of this document).
2. An on-going critical review shall ensure that proposals for new work
and draft standards submitted to the Commission for adoption continue to meet
the strategic priorities of the Commission and can be developed within a
reasonable period of time, taking into account the requirements and availability
of scientific expert advice (See Part 2 of this document).
3. The Commission decides, taking into account the outcome of the on-going
critical review conducted by the Executive Committee, that a standard should be
elaborated and also which subsidiary body or other body should undertake the
work. Decisions to elaborate standards may also be taken by subsidiary bodies
of the Commission in accordance with the above-mentioned outcome subject to
subsequent approval by the Commission at the earliest possible opportunity. The
Secretariat arranges for the preparation of a “proposed draft standard” which is
circulated to governments for comments and is then considered in the light of
these by the subsidiary body concerned which may present the text to the
Commission as a “draft standard”. If the Commission adopts the “draft
standard” it is sent to governments for further comments and in the light of these
and after further consideration by the subsidiary body concerned, the
Commission reconsiders the draft and may adopt it as a “Codex standard”. The
procedure is described in Part 3 of this document.
4. The Commission or any subsidiary body, subject to the confirmation of the
Commission may decide that the urgency of elaborating a Codex standard is
such that an accelerated elaboration procedure should be followed. While taking
this decision, all appropriate matters shall be taken into consideration, including
the likelihood of new scientific information becoming available in the
immediate future. The accelerated elaboration procedure is described in Part 4
19
Elaboration procedures
of this document.
5. The Commission or the subsidiary body or other body concerned may
decide that the draft be returned for further work at any appropriate previous
Step in the Procedure. The Commission may also decide that the draft be held at
Step 8.
6. The Commission may authorise, on the basis of two-thirds majority of votes
cast, the omission of Steps 6 and 7, where such an omission is recommended by
the Codex Committee entrusted with the elaboration of the draft.
Recommendations to omit steps shall be notified to Members and interested
international organizations as soon as possible after the session of the Codex
Committee concerned. When formulating recommendations to omit Steps 6 and
7, Codex Committees shall take all appropriate matters into consideration,
including the need for urgency, and the likelihood of new scientific information
becoming available in the immediate future.
7. The Commission may at any stage in the elaboration of a standard entrust
any of the remaining Steps to a Codex Committee or other body different from
that to which it was previously entrusted.
8. It will be for the Commission itself to keep under review the revision of
“Codex standards”. The procedure for revision should, mutatis mutandis, be that
laid down for the elaboration of Codex standards, except that the Commission
may decide to omit any other step or steps of that Procedure where, in its
opinion, an amendment proposed by a Codex Committee is either of an editorial
nature or of a substantive nature but consequential to provisions in similar
standards adopted by the Commission at Step 8.
9. Codex standards and related texts are published and are sent to
governments as well as to international organizations to which competence in
the matter has been transferred by their Member States (see Part 5 of this
document).
PART 1. STRATEGIC PLANNING PROCESS
1. Taking into account the “Criteria for the Establishment of Work Priorities”,
the strategic plan shall state broad priorities against which individual proposals
for standards (and revision of standards) can be evaluated during the critical
review process.
2. The strategic plan shall cover a six-year period and shall be renewed every
two years on a rolling basis.
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Elaboration procedures
1. Prior to approval for development, each proposal for new work or revision
of a standard, shall be accompanied by a project document, prepared by the
Committee or Member proposing new work or revision of a standard, detailing :
• the purposes and the scope of the standard ;
• its relevance and timeliness ;
• the main aspects to be covered ;
• an assessment against the Criteria for the establishment of work
priorities ;
• relevance to the Codex strategic objectives ;
• information on the relation between the proposal and other existing
Codex documents;
• identification of any requirement for and availability of expert
scientific advice ;
• identification of any need for technical input to the standard from
external bodies so that this can be planned for;
• the proposed time-line for completion the new work, including the start
date, the proposed date for adoption at Step 5, and the proposed date
for adoption by the Commission ; the time frame for developing a
standard should not normally exceed five years.
2. The decision to undertake new work or to revise standards shall be taken by
the Commission taking into account a critical review conducted by the
Executive Committee.
3. The critical review includes:
• examination of proposals for development/revision of standards, taking
into account the “Criteria for the Establishment of Work Priorities",
the strategic plan of the Commission and the required supporting work
of independent risk assessment;
• identifying the standard setting needs of developing countries;
• advice on establishment and dissolution of committees and task forces,
including ad hoc cross-committee task forces (in areas where work
falls within several committee mandates); and
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Elaboration procedures
• preliminary assessment of the need for expert scientific advice and the
availability of such advice from FAO, WHO or other relevant expert
bodies, and the prioritisation of that advice.
4. The decision to undertake new work or revision of individual maximum
residue limits for pesticides or veterinary drugs, or the maintenance of the
3
General Standard on Food Additives , the General Standard on Contaminants
4
and Toxins in Foods , the Food Categorisation System and the International
Numbering System, shall follow the procedures established by the Committees
concerned and endorsed by the Commission.
Monitoring Progress of Standards Development
3
including related methods of analysis and sampling plans
4
including related methods of analysis and sampling plans
22
Elaboration procedures
23
Elaboration procedures
Step 5
The proposed draft standard is submitted through the Secretariat to the
Executive Committee for critical review and to the Commission with a view to
its adoption as a draft standard 5 . In taking any decision at this step, the
Commission will give due consideration to the outcome of the critical review
and to any comments that may be submitted by any of its Members regarding
the implications which the proposed draft standard or any provisions thereof
may have for their economic interests. In the case of Regional Standards, all
Members of the Commission may present their comments, take part in the
debate and propose amendments, but only the majority of the Members of the
region or group of countries concerned attending the session can decide to
amend or adopt the draft. In taking any decisions at this step, the Members of
the region or group of countries concerned will give due consideration to any
comments that may be submitted by any of the Members of the Commission
regarding the implications which the proposed draft standard or any provisions
thereof may have for their economic interests.
Step 6
The draft standard is sent by the Secretariat to all Members and interested
international organizations for comment on all aspects, including possible
implications of the draft standard for their economic interests.
Step 7
The comments received are sent by the Secretariat to the subsidiary body or
other body concerned, which has the power to consider such comments and
amend the draft standard.
Step 8
The draft standard is submitted through the Secretariat to the Executive
Committee for critical review and to the Commission, together with any written
proposals received from Members and interested international organizations for
amendments at Step 8, with a view to its adoption as a Codex standard. In taking
any decision at this step, the Commission will give due consideration to the
outcome of the critical review and to any comments that may be submitted by
5
Without prejudice to the outcome of the critical review conducted by the
Executive Committee and/or any decision that may be taken by the Commission at Step 5,
the proposed draft standard may be sent by the Secretariat for government comments
prior to its consideration at Step 5, when, in the opinion of the subsidiary body or other
body concerned, the time between the relevant session of the Commission and the
subsequent session of the subsidiary body or other body concerned requires such action
in order to advance the work
24
Elaboration procedures
any of its Members regarding the implications which the draft standard or any
provisions thereof may have for their economic interests. In the case of Regional
standards, all Members and interested international organizations may present
their comments, take part in the debate and propose amendments but only the
majority of Members of the region or group of countries concerned attending
the session can decide to amend and adopt the draft.
PART 4. UNIFORM ACCELERATED PROCEDURE FOR THE
ELABORATION OF CODEX STANDARDS AND RELATED TEXTS
Steps 1, 2 and 3
(1) The Commission, on the basis of a two-thirds majority of votes cast, taking
into account the outcome of the critical review conducted by the Executive
Committee, shall identify those standards which shall be the subject of an
accelerated elaboration process.6 The identification of such standards may
also be made by subsidiary bodies of the Commission, on the basis of a
two-thirds majority of votes cast, subject to confirmation at the earliest
opportunity by the Commission.
(2) The Secretariat arranges for the preparation of a proposed draft standard. In
the case of Maximum Limits for Residues of Pesticides or Veterinary
Drugs, the Secretariat distributes the recommendations for maximum limits,
when available from the Joint Meetings of the FAO Panel of Experts on
Pesticide Residues in Food and the Environment and the WHO Core
Assessment Group on Pesticide Residues (JMPR), or the Joint FAO/WHO
Expert Committee on Food Additives (JECFA). Any other relevant
information regarding risk assessment work conducted by FAO and WHO
should also be made available. In the cases of milk and milk products or
individual standards for cheeses, the Secretariat distributes the
recommendations of the International Dairy Federation (IDF).
(3) The proposed draft standard is sent to Members of the Commission and
interested international organizations for comment on all aspects including
possible implications of the proposed draft standard for their economic
interests. When standards are subject to an accelerated procedure, this fact
shall be notified to the Members of the Commission and the interested
international organizations.
Step 4
The comments received are sent by the Secretariat to the subsidiary body or
6
Relevant considerations could include, but need not be limited to, matters
concerning new scientific information; new technology(ies); urgent problems related to
trade or public health; or the revision or up-dating of existing standards.
25
Elaboration procedures
other body concerned which has the power to consider such comments and to
amend the proposed draft standard.
Step 5
In the case of standards identified as being subject to an accelerated elaboration
procedure, the proposed draft standard is submitted through the Secretariat to
the Executive Committee for critical review and to the Commission, together
with any written proposals received from Members and interested international
organizations for amendments, with a view to its adoption as a Codex standard.
In taking any decision at this step, the Commission will give due consideration
to the outcome of the critical review and to any comments that may be
submitted by any of its Members regarding the implications which the proposed
draft standard or any provisions thereof may have for their economic interests.
In the case of Regional standards, all Members and interested international
organizations may present their comments, take part in the debate and propose
amendments but only the majority of Members of the region or group of
countries concerned attending the session can decide to amend and adopt the
proposed draft.
PART 5. SUBSEQUENT PROCEDURE CONCERNING
PUBLICATION OF CODEX STANDARDS
The Codex standard is published and issued to all Member States and Associate
Members of FAO and/or WHO and to the international organizations concerned.
The above mentioned publications will constitute the Codex Alimentarius.
SUBSEQUENT PROCEDURE CONCERNING PUBLICATION AND POSSIBLE
EXTENSION OF TERRITORIAL APPLICATION OF THE STANDARD
The Codex Regional Standard is published and issued to all Member States and
Associate Members of FAO and/or WHO and to the international organizations
concerned.
It is open to the Commission to consider at any time the possible extension of
the territorial application of a Codex Regional Standard or its conversion into a
World-wide Codex Standard.
GUIDE TO THE PROCEDURE FOR THE REVISION AND AMENDMENT OF
CODEX STANDARDS
1. Proposals for the amendment or revision of Codex standards should be
submitted to the Commission’s Secretariat in good time (not less than three
months) before the session of the Commission at which they are to be
considered. The proposer of an amendment should indicate the reasons for the
proposed amendment and should also state whether the proposed amendment
had been previously submitted to and considered by the Codex committee
26
Elaboration procedures
27
Elaboration procedures
28
Elaboration procedures
29
General principles
30
Guidelines on IGO Cooperation
7
“The same principles of membership” shall be taken to mean that the
membership of the organization is open to all Members and Associate Members of FAO
and of WHO.
31
Guidelines on IGO Cooperation
8
“Equivalent principles of standards-setting” refers to the General Decisions of
the Commission set out in the Appendix to the Procedural Manual.
9
See also Article 1 of the Statutes of the Codex Alimentarius Commission, Step
2 of the Uniform Procedure for the Elaboration of Codex Standards and Related Texts,
and the Terms of reference of the Codex Committee on Fresh Fruits and Vegetables.
32
Guidelines on IGO Cooperation
33
Principles concerning NGO Participation
1. PURPOSE
The purpose of collaboration with International Non-Governmental
Organizations is to secure for the Codex Alimentarius Commission, expert
information, advice and assistance from international non-governmental
organizations and to enable organizations which represent important sections of
public opinion and are authorities in their fields of professional and technical
competence to express the views of their members and to play an appropriate
role in ensuring the harmonizing of intersectoral interests among the various
sectoral bodies concerned in a country, regional or global setting. Arrangements
made with such organizations shall be designed to advance the purposes of the
Codex Alimentarius Commission by securing maximum cooperation from
International Non-Governmental Organizations in the execution of its
programme.
2. TYPES OF RELATIONSHIP
Only one category of relationship shall be recognized, namely “Observer
Status”; all other contacts, including working relations, shall be considered to be
of an informal character.
10
The term “subsidiary bodies” means any body established under Rule XI of the
Commission's Rules of Procedure.
35
Principles concerning NGO Participation
consult with the Directors-General of FAO and WHO and may seek further
information and clarifications from the Organization as appropriate.
Upon satisfactory completion of the verification and assessment referred to in
the previous paragraph, the Secretary of the Commission will submit the
application and all relevant information received from the applicant to the
Executive Committee for its advice, pursuant to Rule IX.6 of the Rules of
Procedure of the Codex Alimentarius Commission.
The Secretary of the Commission will transmit the application, together with all
relevant information received from the applicant and the advice of the Executive
Committee, to the Directors-General who will decide whether an Organization
is to be granted observer status. In case of rejection of an application, a re-
application by the same Organization shall not normally be considered until two
years have elapsed since the Directors-General's decision on the original
application.
The Secretary of the Commission shall inform each Organization of the
Directors-General's decision on its application, and shall provide a written
explanation of the decision in case of rejection.
Observer Status at specific meetings will not normally be granted to individual
organizations that are members of a larger organization authorized and that
intends to represent them at these meetings.
5. PRIVILEGES AND OBLIGATIONS
International Non-governmental Organizations in Observer status shall
have the following privileges and obligations:
5.1 Privileges of International Non-Governmental Organizations in
"Observer Status"
An Organization in Observer Status:
(a) shall be entitled to send an observer (without the right to vote) to sessions of
the Commission, who may be accompanied by advisers; to receive from the
Secretary of the Commission, in advance of the session, all working documents
and discussion papers; to circulate to the Commission its views in writing,
without abridgement; and to participate in discussions when invited by the
Chairperson11;
11
An invitation to a Codex meeting and representation thereat by an observer
shall not imply the granting to an international non-governmental organization of a status
different from that which it already enjoys.
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Principles concerning NGO Participation
(b) shall be entitled to send an observer (without the right to vote) to sessions of
specified Subsidiary Bodies, who may be accompanied by advisers; to receive
from the Secretaries of the Subsidiary Bodies, in advance of the session, all
working documents and discussion papers; to circulate to these Bodies its views
in writing, without abridgement; and to participate in discussions when invited
by the Chairperson;
(c) may be invited by the Directors-General to participate in meetings or
seminars on subjects organized under the Joint FAO/WHO Food Standards
Programme which fall within its fields of interest, and if it does not so
participate it may submit its views in writing to any such meeting or seminar;
(d) will receive documentation and information about meetings planned
on subjects agreed upon with the Secretariat;
(e) may submit, under the authority of its governing body, written statements on
matters before the Commission, in one of the languages of Commission, to the
Secretary, who may communicate them to the Commission or the Executive
Committee as appropriate.
5.2 Obligations of International Non-Governmental Organizations in
"Observer Status"
An Organization in Observer Status shall undertake:
(a) to cooperate fully with the Codex Alimentarius Commission for the furtherance of the
objectives of the Joint FAO/WHO Food Standards Programme;
(b) in cooperation with the Secretariat, to determine the ways and means of co-
ordinating activities within the scope of the Joint FAO/WHO Food Standards
Programme, with a view to avoiding duplication and overlapping;
(c) to contribute, as far as possible, and at the request of the Directors-General,
to the promotion of a better knowledge and understanding of the Codex
Alimentarius Commission and the Joint FAO/WHO Food Standards Programme
through appropriate discussions or other forms of publicity;
(d) to send to the Secretary of the Commission on an exchange basis, its reports
and publications concerned with matters covering all or part of the
Commission’s field of activity;
(e) to promptly report to the Secretary of the Commission changes it its structure
and membership, important changes in its secretariat as well as any other
important changes in the information provided in accordance with the Annex to
the present Principles.
37
Principles concerning NGO Participation
38
Principles concerning NGO Participation
39
Principles concerning NGO Participation
(l) Previous applications for observer status with the Codex Alimentarius
Commission, including those made by a member organization of the applicant
organization. If successful, please indicate why and when observer status was
terminated. If unsuccessful, please indicate the reasons you were given.
(m) Languages (English, French or Spanish) in which documentation should be
sent to the international non-governmental organization
(n) Name, Function and address of the person providing the information
(o) Signature and date
40
Definitions
41
Definitions
42
Definitions
43
Definitions
44
Definitions
45
Section II
SECTION II
Guidelines for Codex Committees and Task Forces
Criteria for Work Priorities and for Establishing Subsidiary Bodies
Guidelines for the Inclusion of Specific Provisions in Codex Standards
Reference System for Documents
Format for Codex Commodity Standards
Relations between Codex Committees
Core Functions of Codex Contact Points
46
Guidelines for Committees
OBSERVERS
Any other Member of the Commission or any Member or Associate Member of
FAO or WHO which has not become a Member of the Commission may
participate as an observer at any Codex Committee if it has notified the
Director-General of FAO or WHO of its wish to do so. Such countries may
participate fully in the discussions of the Committee and shall be provided with
the same opportunities as other Members to express their point of view
(including the submission of memoranda), but without the right to vote or to
move motions either of substance or of procedure. International organizations
which have formal relations with either FAO or WHO should also be invited to
47
Guidelines for Committees
SECRETARIAT
A member country to which a Codex Committee has been assigned is
responsible for providing all conference services including the secretariat. The
secretariat should have adequate administrative support staff able to work easily
in the languages used at the session and should have at its disposal adequate
word processing and document reproducing equipment. Interpretation,
preferably simultaneous, should be provided from and into all languages used at
the session, and if the report of the session is to be adopted in more than one of
the working languages of the Committee, then the services of a translator should
be available. The Committee secretariat and the Joint FAO/WHO (Codex)
Secretariat are charged with the preparation of the draft report in consultation
with the rapporteurs, if any.
(e) reporting to each session of the Commission on the progress of its work
and, where necessary, on any difficulties caused by its terms of reference,
together with suggestions for their amendment.
(f) the review and, as necessary, revision of existing standards and related
texts on a scheduled, periodic basis to ensure that the standards and
related texts within its terms of reference are consistent with current
scientific knowledge and other relevant information.
SESSIONS
DATE AND PLACE
A member country to which a Codex Committee has been assigned is consulted
by the Directors-general of FAO and WHO before they determine when and
where a session of this Committee shall be convened.
The member country should consider arrangements for holding Codex sessions
in developing countries.
49
Guidelines for Committees
The Provisional Agenda should state the time, date and place of the meeting and
should include the following items:
(a) adoption of the agenda,
(b) if considered necessary, election of rapporteurs,
(c) items relating to subject matter to be discussed, including, where
appropriate, the step in the Commission’s Procedure for the Elaboration
of Standards at which the item is being dealt with at the session. There
should also be reference to the Committee papers relevant to the item,
(d) any other business,
(e) consideration of date and place of next session,
(f) adoption of draft report.
The work of the Committee and the length of the meeting should be so arranged
as to leave sufficient time at the end of the session for a report of the
Committee’s transactions to be agreed.
ORGANIZATION OF WORK
A Codex or Coordinating Committee may assign specific tasks to countries,
groups of countries or to international organizations represented at meetings of
the Committee and may ask member countries and international organizations
for views on specific points.
Ad hoc working groups established to accomplish specific tasks shall be
50
Guidelines for Committees
12
See Uniform System of References for Codex Documents.
51
Guidelines for Committees
paper immediately under the title. The text should be divided into numbered
paragraphs. At the end of these guidelines is a series of references for Codex
documents adopted by the Codex Alimentarius Commission for its own sessions
and those of its subsidiary bodies.
Members of the Codex Committees should advise the Committee chairperson
through their Codex Contact Point of the number of copies of documents
normally required.
Working papers of Codex Committees may be circulated freely to all those
assisting a delegation in preparing for the business of the Committee; they
should not, however, be published. There is, however, no objection to the
publication of reports of the meetings of Committees or of completed draft
standards.
52
Guidelines for Committees
CONDUCT OF MEETINGS
Meetings of Codex and Coordinating Committees shall be held in public unless
the Committee decides otherwise. Member countries responsible for Codex and
Coordinating Committees shall decide who should open meetings on their
behalf.
Meetings should be conducted in accordance with the Rules of Procedure of the
Codex Alimentarius Commission.
Only the chief delegates of members, or of observer countries or of international
organizations have the right to speak unless they authorize other members of
their delegations to do so.
The representative of a regional economic integration organization shall provide
the chairperson of the Committee, before the beginning of each session, with a
written statement outlining where the competence lies between this organization
and its members for each item, or subparts thereof, as appropriate, of the
provisional agenda, pursuant to the Declaration of Competence submitted
according to Rule II of the Rules of Procedure of the Codex Alimentarius
Commission by this organization. In areas of shared ("mixed") competence
between this organization and its members, this statement shall make clear
which party has the voting right.
Delegations and delegations from observer countries who wish their opposition
to a decision of the Committee to be recorded may do so, whether the decision
has been taken by a vote or not, by asking for a statement of their position to be
contained in the report of the Committee. This statement should not merely use
53
Guidelines for Committees
a phrase such as: “The delegation of X reserved its position” but should make
clear the extent of the delegation’s opposition to a particular decision of the
Committee and state whether they were simply opposed to the decision or
wished for a further opportunity to consider the question.
REPORTS
In preparing reports, the following points shall be borne in mind:
(a) decisions should be clearly stated; action taken in regard to economic
impact statements should be fully recorded; all decisions on draft standards
should be accompanied by an indication of the step in the Procedure that
the standards have reached;
(b) if action has to be taken before the next meeting of the Committee, the
nature of the action, who is to take it and when the action must be
completed should be clearly stated;
(c) where matters require attention by other Codex Committees, this should be
clearly stated;
(d) if the report is of any length, summaries of points agreed and the action to
be taken should be included at the end of the report, and in any case, a
section should be included at the end of the report showing clearly in
summary form:
- standards considered at the session and the steps they have reached;
- standards at any step of the Procedure, the consideration of which has
been postponed or which are held in abeyance and the steps which they
have reached;
- new standards proposed for consideration, the probable time of their
consideration at Step 2 and the responsibility for drawing up the first
draft.
54
Guidelines for Committees
55
Guidelines for Committees
DESIGNATION
The Codex Alimentarius Commission will designate a member country of the
Commission, which has indicated its willingness to accept financial and all
other responsibility, as having responsibility for appointing a chairperson of the
Committee. The member country concerned is responsible for appointing the
chairperson of the Committee from among its own nationals. Should this person
for any reason be unable to take the chair, the member country concerned shall
designate another person to perform the functions of the chairperson for as long
as the chairperson is unable to do so.
56
Guidelines for Committees
The following criteria may be considered during the selection of the appointee:
• to be a national of the member country responsible for appointing the
chairperson of the Committee;
• to have a general knowledge in the fields of the subsidiary body
concerned and to be able to understand and analyse technical issues;
• insofar as possible, to be able to serve in a continuing capacity;
• to be familiar with the system of Codex and its rules, and to have
experience in the work of relevant international, governmental or non-
governmental organizations;
• to be able to communicate clearly both orally and in writing in one of
the working languages of the Commission;
• to have demonstrated ability in chairing meetings with objectivity and
impartiality, and in facilitating consensus building;
• to exercise tact and sensitivity to issues of particular importance to
members of the Commission;
• not to engage and/or not to have engaged in activities which could give
rise to a conflict of interest on any item on the agenda of the
Committee.
CONDUCT OF MEETINGS
The chairperson should invite observations from members of the Committee
concerning the Provisional Agenda and in the light of such observations
formally request the Committee to adopt the Provisional Agenda or the amended
agenda.
Meetings should be conducted in accordance with the Rules of Procedure of the
Codex Alimentarius Commission. Attention is particularly drawn to Rule VIII.7
which reads: “The provisions of Rule XII of the General Rules of FAO shall
apply mutatis mutandis to all matters which are not specifically dealt with under
Rule VIII of the present Rules.”
Rule XII of the General Rules of FAO, a copy of which will be supplied to all
chairpersons of Codex and Coordinating Committees, gives full instructions on
the procedures to be followed in dealing with voting, points of order,
adjournment and suspension of meetings, adjournment and closure of
discussions on a particular item, reconsideration of a subject already decided
and the order in which amendments should be dealt with.
Chairpersons of Codex Committees should ensure that all questions are fully
discussed, in particular statements concerning possible economic implications of
standards under consideration at Steps 4 and 7.
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Guidelines for Committees
Chairpersons should also ensure that the written comments, received in a timely
manner, of members and observers not present at the session are considered by
the Committee; that all issues are put clearly to the Committee. This can usually
best be done by stating what appears to be the generally acceptable view and
asking delegates whether they have any objection to its being adopted.
Chairpersons should use the statement submitted by the representatives of the
regional economic integration organizations on the matters of respective
competence between these organizations and their members in the conduct of
meetings, including assessing of the situation with regard to the party which has
the right to vote.
CONSENSUS13
The chairpersons should always try to arrive at a consensus and should not ask
the Committee to proceed to voting if agreement on the Committee’s decision
can be secured by consensus.
The Procedure for the Elaboration of Codex Standards and Related Texts
allows for full discussion and exchange of views on the issue under
consideration, in order to ensure the transparency of the process and arrive at
compromises that would facilitate consensus.
Much of the responsibility for facilitating the achievement of consensus would
lie in the hands of the Chairpersons.
When working out the means of progressing the work of a Committee, the
chairperson should consider:
(a) the need for timely progress in developing standards ;
(b) the need to achieve consensus among the members as to the content of,
and justification for, proposed standards;
(c) the importance of achieving consensus at all stages of the elaboration of
standards and that draft standards should, as a matter of principle, be
submitted to the Commission for adoption only where consensus has
been achieved at the technical level.
The chairperson should also consider implementing the following measures in
order to facilitate consensus building in the elaboration of standards at the
Committee stage:
13
Reference is made to the Measures to facilitate consensus (see Appendix:
General Decisions of the Codex Alimentarius Commission).
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Guidelines for Committees
(a) ensuring that: (i) the scientific basis is well established on current data
including, wherever possible, scientific data and intake and exposure
information from the developing countries; (ii) where data from
developing countries are not available, an explicit request for collecting
and making available such data is made; and (iii) where necessary,
further studies are carried out in order to clarify controversial issues;
(b) ensuring that issues are thoroughly discussed at meetings of the
Committees concerned;
(c) organizing informal meetings of the parties concerned where
disagreements arise, provided that the objectives of any such meetings
are clearly defined by the Committee concerned and that participation is
open to all interested delegations and observers in order to preserve
transparency;
(d) requesting the Commission, where possible, for a redefinition of the
scope of the subject matter being considered for the elaboration of
standards in order to cut out issues on which consensus cannot be
reached;
(e) ensuring that matters are not progressed from step to step until all
relevant concerns are taken into account and adequate compromises
worked out14;
(f) facilitating increased involvement and participation of developing
countries.
14
This does not preclude square bracketing of parts of a text in the early stages of
the elaboration of a standard, where there is consensus on the large majority of the text.
59
Guidelines for Committees
15
The provisions of the "Guidelines to Host Governments of Codex Committees
and ad hoc Intergovernmental Task Forces", the "Guidelines on the Conduct of Meetings
of Codex Committees and ad hoc Intergovernmental Task Forces" and the "Guidelines to
Chairpersons of Codex Committees and ad hoc Intergovernmental Task Forces" are
especially relevant in this matter.
60
Guidelines for Committees
CHAIRPERSON
The Host is responsible for appointing the chairperson of the working group.
While selecting of the appointee, the Host may consider applying, where
relevant, the Codex Criteria for the Appointment of Chairpersons16.
SECRETARIAT
The Host is responsible for providing all conference services, including the
secretariat, for the working group and should meet all the requirements agreed
upon by the Committee, when the working group was established.
DUTIES AND TERMS OF REFERENCE
The terms of reference of the working group shall be established by the
Committee during its plenary session, shall be limited to the immediate task at
hand and normally shall not be subsequently modified.
The terms of reference shall clearly state the objective(s) to be achieved by the
establishment of the working group and the language(s) to be used.
Interpretation and translation services should be provided in all languages of the
Committee, unless decided otherwise by the Committee.
The terms of reference shall clearly state the time frame by which the work is
expected to be completed. The proposals/recommendations of a working group
shall be presented to the Committee for consideration.
They shall not be binding on the Committee.
The working group shall be dissolved after the specified work has been
completed or when the time limit allocated for the work has expired or at any
other point in time, if the Codex Committee which has established it, so decides.
No decision on behalf of the Committee, nor vote, either on point of substance
or of procedure, shall take place in working groups.
SESSIONS
DATE
A session of a working group may be held at any time, in-between two sessions
or in conjunction with the session of the Committee, which has established it.
When convened in-between two sessions of the Committee, the session of the
working group should be scheduled as to allow the working group to report to
the Committee well in advance of the next meeting so that countries and other
16
Reference is made to the Guidelines to Chairpersons of Codex Committees and
ad hoc Intergovernmental Task Forces.
61
Guidelines for Committees
interested parties, that were not members of the working group, can comment on
the proposals that the working group might put to the Committee.
When convened during a session of a Committee, a working group should be
scheduled so as to allow participation of all delegations present at the session.
WORKING GROUP NOTIFICATION AND PROVISIONAL AGENDA
Sessions of a working group shall be convened by the Chairperson designated
by the Host.
If the working group is scheduled in-between two sessions of the Committee, a
notice of the working group meeting and provisional agenda shall be prepared,
translated and distributed by the Host. It shall be issued to all Members and
Observers who have expressed the willingness to attend the meeting. These
documents should be distributed as far in advance of the meeting as possible.
ORGANIZATION OF WORK
Written comments will be circulated to all concerned by the secretariat of the
Host.
PREPARATION AND DISTRIBUTION OF PAPERS
The secretariat of the Host should circulate the papers at least two months
before the opening of the session.
Paper for the session prepared by the participants should be sent to the
secretariat of the Host, in good time.
CONCLUSIONS
The Secretariat of the Host should, as soon as possible after the end of the
session of a working group, send a copy of the final conclusions, in the form of
either a discussion paper or a working document, and the list of participants, to
the Joint FAO/WHO Secretariat and to the host country secretariat of the
Committee.
Conclusions of a working group shall be distributed to all Codex Contact Points
and observers by the Joint FAO/WHO Secretariat in time to allow full
consideration of the working group’s recommendations.
The Joint FAO/WHO Secretariat should ensure that these conclusions are
included in the distribution of papers for the next session of the Codex
Committee.
The working group shall report, through its Chairperson, on the progress of its
work at the next session of the Committee, which has established the working
group.
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Guidelines for Committees
17
The provisions of the "Guidelines to Host Governments of Codex Committees
and ad hoc Intergovernmental Task Forces", the "Guidelines on the Conduct of Meetings
of Codex Committees and ad hoc Intergovernmental Task Forces", the "Guidelines to
Chairpersons of Codex Committees and ad hoc Intergovernmental Task Forces" and the
"Guidelines on Physical Working Groups" are especially relevant in this matter.
63
Guidelines for Committees
64
Guidelines for Committees
66
Work priorities
67
Work priorities
Note
In order to satisfy the criterion that the proposed new chemical is a “safer” or
“reduced risk” replacement chemical, the nominating country is required to
provide:
i the name(s) of the chemicals for which the proposed chemical is likely
to be an alternative;
ii a comparison of the acute and chronic toxicities of the proposed
chemical with other chemicals in its classification (insecticide, fungicide,
herbicide);
iii a summary of acute and chronic dietary exposure calculations
encompassing the range of diets considered by CCPR; and
iv other relevant information to support classification of the proposed
chemical as a safer alternative chemical.
2.2 Periodic Re-Evaluation
When prioritizing chemicals for periodic re-evaluation by the JMPR, the
Committee will consider the following criteria:
1. If the intake and/or toxicity profile indicate some level of public
health concern;
2. Chemicals that have not been reviewed toxicologically for more than
15 years and/or not having a significant review of maximum residue limits for
15 years;
3. The year the chemical is listed in the list for Candidate Chemicals for
Periodic Re-evaluation –Not Yet Scheduled;
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Work priorities
69
Work priorities
Note:
Where a pesticide has already been evaluated by the JMPR and MRLs, EMRLs
or GLs have been established, new evaluations may be initiated if one or more
of the following situations arise:
i New toxicological data becomes available to indicate a significant
change in the ADI or ARfD.
ii The JMPR may note a data deficiency in a Periodic Re-evaluation or
New Chemical evaluation. In response, national governments or other
interested parties may pledge to supply the information to the
appropriate Joint Secretary of the JMPR with a copy for consideration
by the CCPR. Following scheduling in the JMPR tentative schedule,
the data should be submitted subsequently to the appropriate Joint
Secretary of the JMPR.
iii The CCPR may place a chemical under the four-year rule, in which
case the government or industry should indicate support for the
specific MRLs to the FAO Joint Secretary of the JMPR. Following
scheduling in the JMPR tentative schedule, any data in support of
maintenance of the MRL(s) would be submitted to the FAO Joint
Secretary of the JMPR.
iv A government member may seek to expand the use of an existing
Codex chemical: that is, obtain MRLs for one or more new
commodities where some MRLs already exist for other commodities.
Such requests should be directed to the FAO Joint Secretary of the
JMPR and submitted for consideration by the CCPR. Following
scheduling in the JMPR tentative schedule, the data would be
submitted to the FAO Joint Secretary of the JMPR.
v A government member may seek to review a MRL due to a change in
GAP. For example a new GAP may necessitate a larger MRL. In this
case the request should be made to the FAO Joint Secretary with a
copy for consideration by the Committee. Following scheduling in the
JMPR tentative schedule, the data would be submitted to the FAO
Joint Secretary of the JMPR.
vi The CCPR may request a clarification or reconsideration of a
recommendation from the JMPR. In such cases the relevant Joint
Secretary will schedule the request for the next JMPR.
vii A serious public health concern may emerge in relation to a particular
pesticide for which MRLs exist. In such cases government members
should notify the WHO Joint Secretary of the JMPR promptly and
provide appropriate data to the WHO Joint Secretary.
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Criteria for subsidiary bodies
18
The Commission may wish to consider extending the Terms of Reference of an
appropriate existing body to accommodate the proposal.
71
Criteria for subsidiary bodies
3. OPERATING EXPENSES
No provision shall be made concerning the operating expenditures of the ad hoc
Intergovernmental Task Force in the estimate of expenditures of the Joint
FAO/WHO Food Standards Programme, except insofar as costs involved in
preparatory work are recognized as operating expenses of the Commission in
accordance with Article 10 of its Statutes.
4. HOST GOVERNMENT ARRANGEMENTS
The Commission, at the time of the establishment of the ad hoc
Intergovernmental Task Force, shall ascertain that there will be appropriate host
government arrangements adequate to ensure the functioning of the Task Force
for the duration of its assignment.19
5. WORKING PROCEDURES
Ad hoc Intergovernmental Task Forces shall be open to all Members of the
Commission and the Rules of Procedure of the Codex Alimentarius
Commission and the Uniform Procedure for the Elaboration of Codex Standards
and Related Texts shall apply mutatis mutandis to ad hoc Intergovernmental
Task Forces.
6. DISSOLUTION
The ad hoc Intergovernmental Task Force shall be dissolved after the specified
work has been completed or when the number of sessions or the time limit
allocated for the work has expired.
19
This may involve Host Government arrangements with one or more Members
of the Commission.
72
Specific provisions in Codex texts
73
Specific provisions in Codex texts
METHODS OF ANALYSIS
Definition of types of methods of analysis
(a) Defining Methods (Type I)
Definition: A method which determines a value that can only be arrived at in
terms of the method per se and serves by definition as the only method for
establishing the accepted value of the item measured.
Examples: Howard Mould Count, Reichert-Meissl value, loss on drying, salt in
brine by density.
(b) Reference Methods (Type II)
Definition: A Type II method is the one designated Reference Method where
Type I methods do not apply. It should be selected from Type III methods (as
defined below). It should be recommended for use in cases of dispute and for
calibration purposes.
Example: Potentiometric method for halides.
(c) Alternative Approved Methods (Type III)
Definition: A Type III Method is one which meets the criteria required by the
Codex Committee on Methods of Analysis and Sampling for methods that may
be used for control, inspection or regulatory purposes.
Example: Volhard Method or Mohr Method for chlorides
(d) Tentative Method (Type IV)
Definition: A Type IV Method is a method which has been used traditionally or
else has been recently introduced but for which the criteria required for
acceptance by the Codex Committee on Methods of Analysis and Sampling
have not yet been determined.
Examples: chlorine by X-ray fluorescence, estimation of synthetic colours in
foods.
General Criteria for the Selection of Methods of Analysis
(a) Official methods of analysis elaborated by international organizations
occupying themselves with a food or group of foods should be preferred.
(b) Preference should be given to methods of analysis the reliability of which
have been established in respect of the following criteria, selected as
appropriate:
(i) specificity
(ii) accuracy
74
Specific provisions in Codex texts
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Specific provisions in Codex texts
• linearity
CCMAS will generate the data corresponding to the above criteria.
CONVERSION OF SPECIFIC METHODS OF ANALYSIS TO METHOD
CRITERIA BY THE CCMAS
When a Codex Commodity Committee submits a Type II or Type III method to
CCMAS for endorsement, it should also submit information on the criteria listed
below to enable the CCMAS to convert it into suitable generalized analytical
characteristics:
• accuracy
• applicability (matrix, concentration range and preference given to
'general' methods)
• detection limit
• determination limit
• precision; repeatability intra-laboratory (within laboratory),
reproducibility inter-laboratory (within laboratory and between
laboratories), but generated from collaborative trial data rather than
measurement uncertainty considerations
• recovery
• selectivity
• sensitivity
• linearity
These terms are defined in the Analytical Terminology for Codex Use, as are
other terms of importance.
The CCMAS will assess the actual analytical performance of the method which
has been determined in its validation. This will take account of the appropriate
precision characteristics obtained in collaborative trials which may have been
carried out on the method together with results from other development work
carried out during the course of the method development. The set of criteria that
are developed will form part of the report of the CCMAS and will be inserted in
the appropriate Codex Commodity Standard.
In addition, the CCMAS will identify numeric values for the criteria for which it
would wish such methods to comply.
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Specific provisions in Codex texts
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Specific provisions in Codex texts
Trueness: The closeness of agreement between the average value obtained from
a series of test results and an accepted reference value.
Notes:
1 The measure of trueness is usually expressed in terms of bias.
2 Trueness has been referred to as “accuracy of the mean”. This usage is
not recommended.
Bias: The difference between the expectation of the test results and an accepted
reference value.
Notes:
Bias is the total systematic error as contrasted to random error. There may be
one or more systematic error components contributing to bias. A larger
systematic difference from the accepted reference value is reflected by a larger
bias value.
When the systematic error component(s) must be arrived at by a process that
includes random error, the random error component is increased by propagation
of error considerations and reduced by replication.
Precision: The closeness of agreement between independent test results
obtained under stipulated conditions.
Notes:
Precision depends only on the distribution of random errors and does not relate
to the true value or to the specified value.
The measure of precision is usually expressed in terms of imprecision and
computed as a standard deviation of the test results. Less precision is reflected
by a larger standard deviation.
“Independent test results” means results obtained in a manner not influenced by
any previous result on the same or similar test object. Quantitative measures of
precision depend critically on the stipulated conditions. Repeatability and
reproducibility conditions are particular sets of extreme conditions.
Repeatability [Reproducibility]: Precision under repeatability [reproducibility]
conditions.
Repeatability conditions: Conditions where independent test results are
obtained with the same method on identical test items in the same laboratory by
the same operator using the same equipment within short intervals of time.
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Specific provisions in Codex texts
Reproducibility conditions: Conditions where test results are obtained with the
same method on identical test items in different laboratories with different
operators using different equipment.
Notes:
When different methods give test results that do not differ significantly, or when
different methods are permitted by the design of the experiment, as in a
proficiency study or a material-certification study for the establishment of a
consensus value of a reference material, the term “reproducibility” may be
applied to the resulting parameters. The conditions must be explicitly stated.
Repeatability [Reproducibility] standard deviation: The standard deviation of
test results obtained under repeatability [reproducibility] conditions.
Notes:
Repeatability [Reproducibility] standard deviation is a measure of the dispersion
of the distribution of test results under repeatability [reproducibility] conditions.
Similarly “repeatability [reproducibility] variance” and “repeatability
[reproducibility] coefficient of variation” could be defined and used as
measures of the dispersion of test results under repeatability [reproducibility]
conditions.
Repeatability [Reproducibility] limit: The value less than or equal to which the
absolute difference between two test results obtained under repeatability
[reproducibility] conditions may be expected to be with a probability of 95%.
Notes:
The symbol used is r [R].
When examining two single test results obtained under repeatability
[reproducibility] conditions, the comparison should be made with the
repeatability [reproducibility] limit r [R] = 2.8 sr[sR].
When groups of measurements are used as the basis for the calculation of the
repeatability [reproducibility] limits (now called the critical difference), more
complicated formulae are required that are given in ISO 5725-6:1994, 4.2.1 and
4.2.2.
Interlaboratory Study: A study in which several laboratories measure a
quantity in one or more “identical” portions of homogeneous, stable materials
under documented conditions, the results of which are compiled into a single
document.
Notes:
The larger the number of participating laboratories, the greater the confidence
that can be placed in the resulting estimates of the statistical parameters. The
80
Specific provisions in Codex texts
82
Specific provisions in Codex texts
Although the signal may vary with the magnitude of ci or qi, the slope, si, is
usually constant over a reasonable range of concentrations. si may also be a
function of the c or q of other analytes present in the sample.
Ruggedness: The ability of a chemical measurement process to resist changes
in results when subjected to minor changes in environmental and procedural
variables, laboratories, personnel, etc.
TERMS TO BE USED IN THE CRITERIA APPROACH
Detection Limit: The detection limit is conventionally defined as field blank +
3σ, where is the standard deviation of the field blank value signal (IUPAC
definition).
However, an alternative definition which overcomes most of the objections to
the above approach (i.e. the high variability at the limit of measurement can
never be overcome) is to base it on the rounded value of the reproducibility
relative standard deviation when it goes out of control (where 3 σR = 100%; σR
= 33%, rounded to 50% because of the high variability). Such a value is directly
related to the analyte and to the measurement system and is not based on the
local measurement system.
Determination limit: As for detection limit except that 6 or 10 is required rather
than 3.
However, an alternative definition that corresponds to that proposed for the
detection limit is to use σR = 25%. This value does not differ much from that
assigned to the detection limit because the upper limit of the detection limit
merges indistinguishably into the lower limit of the determination limit.
Recovery: Proportion of the amount of analyte present or added to the test
material which is extracted and presented for measurement.
Selectivity: Selectivity is the extent to which a method can determine particular
analyte(s) in mixtures or matrices without interferences from other components
of similar behaviour.
Selectivity is the recommended term in analytical chemistry to express the extent
to which a particular method can determine analyte(s) in the presence of
interferences from other components. Selectivity can be graded. The use of the
term specificity for the same concept is to be discouraged as this often leads to
confusion.
Linearity: The ability of a method of analysis, within a certain range, to provide
an instrumental response or results proportional to the quality of analyte to be
determined in the laboratory sample. This proportionality is expressed by an a
priori defined mathematical expression. The linearity limits are the
experimental limits of concentrations between which a linear calibration model
83
Specific provisions in Codex texts
20
Codex Alimentarius: Volume 13.
84
Specific provisions in Codex texts
(c) In the Codex methods of analysis, provision should be made for variations
in reagent concentrations and specifications from country to country.
(d) Codex methods of analysis which have been derived from scientific
journals, theses, or publications, either not readily available or available in
languages other than the official languages of FAO and WHO, or which for
other reasons should be printed in the Codex Alimentarius in extenso, should
follow the standard layout for methods of analysis as adopted by the Codex
Committee on Methods of Analysis and Sampling.
(e) Methods of analysis which have already been printed as official methods
of analysis in other available publications and which are adopted as Codex
methods need only be quoted by reference in the Codex Alimentarius.
THE USE OF ANALYTICAL RESULTS: SAMPLING PLANS,
RELATIONSHIP BETWEEN THE ANALYTICAL RESULTS, THE
MEASUREMENT UNCERTAINTY, RECOVERY FACTORS AND
PROVISIONS IN CODEX STANDARDS
ISSUES INVOLVED
There are a number of analytical and sampling considerations which prevent
the uniform implementation of legislative standards. In particular, different
approaches may be taken regarding sampling procedures, the use of
measurement uncertainty and recovery corrections.
At present there is no official guidance on how to interpret analytical results in
the framework of Codex. Significantly different decisions may be taken after
analysis of the “same sample”. For example some countries use an “every-
item-must-comply” sampling regime, others use an “average of a lot” regime,
some deduct the measurement uncertainty associated with the result, others do
not, some countries correct analytical results for recovery, others do not. This
interpretation may also be affected by the number of significant figures
included in any commodity specification.
It is essential that analytical results be are interpreted in the same way if there
is to be harmonization in the framework of Codex.
It is stressed that this is not an analysis or sampling problem as such but an
administrative problem which has been highlighted as the result of recent
activities in the analytical sector, most notably the development of International
Guidelines on the Use of Recovery Factors when Reporting Analytical Results
and various Guides prepared dealing with Measurement Uncertainty.
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Specific provisions in Codex texts
RECOMMENDATIONS
It is recommended that when a Codex Commodity Committee discusses and
agrees on a commodity specification and the analytical methods concerned, it
states the following information in the Codex Standard:
1. Sampling Plans
The appropriate sampling plan, as outlined in the Guidelines for Sampling
(CAC/GL 50-2004), Section 2.1.2 Guidelines on Sampling to control
conformity of products with the specification. This should state:
whether the specification applies to every item in a lot, or to the
average in a lot, or the proportion non-conforming;
the appropriate acceptable quality level to be used;
the acceptance conditions of a lot controlled, in relation to the
qualitative/quantitative characteristic determined on the sample.
2. Measurement Uncertainty
An allowance is to be made for the measurement uncertainty when deciding
whether or not an analytical result falls within the specification. This
requirement may not apply in situations when a direct health hazard is
concerned, such as for food pathogens.
3. Recovery
Analytical results are to be expressed on a recovery corrected basis where
appropriate and relevant, and when corrected it has to be so stated.
If a result has been corrected for recovery, the method by which the recovery
was taken into account should be stated. The recovery rate is to be quoted
wherever possible.
When laying down provisions for standards, it will be necessary to state
whether the result obtained by a method used for analysis within conformity
checks shall be expressed on an recovery-corrected basis or not..
4. Significant Figures
The units in which the results are to be expressed and the number of significant
figures to be included in the reported result.
87
Document reference system
Subsidiary Bodies
Codex Committees
General Principles CX/GP
Food Additives CX/FA
Contaminants CX/CF
Food Hygiene CX/FH
Food Labelling CX/FL
Methods of Analysis and Sampling CX/MAS
Pesticide Residues CX/PR
Residues of Veterinary Drugs in Foods CX/RVDF
Food Import and Export Inspection and Certification CX/FICS
Systems
Nutrition and Foods for Special Dietary Uses CX/NFSDU
Cereals, Pulses and Legumes CX/CPL
88
Document reference system
89
Document reference system
90
Format for commodity standards
INTRODUCTION
The Format is also intended for use as a guide by the subsidiary bodies of the
Codex Alimentarius Commission in presenting their standards, with the object
of achieving, as far as possible, a uniform presentation of commodity standards.
The Format also indicates the statements which should be included in standards
as appropriate under the relevant headings of the standard. The sections of the
Format require to be completed in a standard only insofar as such provisions are
appropriate to an international standard for the food in question.
NAME OF THE STANDARD
SCOPE
DESCRIPTION
ESSENTIAL COMPOSITION AND QUALITY FACTORS
FOOD ADDITIVES
CONTAMINANTS
HYGIENE
WEIGHTS AND MEASURES
LABELLING
METHODS OF ANALYSIS AND SAMPLING
NOTES ON THE HEADINGS
NAME OF THE STANDARD
The name of the standard should be clear and as concise as possible. It should
usually be the common name by which the food covered by the standard is
known or, if more than one food is dealt with in the standard, by a generic name
covering them all. If a fully informative title should be inordinately long, a
subtitle could be added.
SCOPE
This section should contain a clear, concise statement as to the food or foods to
which the standard is applicable unless this is self-explanatory in the name of
the standard. In the case of a general standard covering more than one specific
product, it should be made clear as to which specific products the standard
applies.
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Format for commodity standards
DESCRIPTION
This section should contain a definition of the product or products with an
indication, where appropriate, of the raw materials from which it is derived and
any necessary references to processes of manufacture. It may also include
references to types and styles of product and to type of pack. There may also be
additional definitions when these are required to clarify the meaning of the
standard.
ESSENTIAL COMPOSITION AND QUALITY FACTORS
This section should contain all quantitative and other requirements as to
composition including, where necessary, identity characteristics, provisions on
packing media and requirements as to compulsory and optional ingredients. It
should also include quality factors which are essential for the designation,
definition or composition of the product concerned. Such factors could include
the quality of the raw material, with the object of protecting the health of the
consumer, provisions on taste, odour, colour and texture which may be
apprehended by the senses, and basic quality criteria for the finished products,
with the object of preventing fraud. This section may refer to tolerances for
defects, such as blemishes or imperfect material, but this information should be
contained in an appendix to the standard or in another advisory text.
FOOD ADDITIVES
This section should contain the names of the additives permitted and, where
appropriate, the maximum amount permitted in the food. It should be prepared
in accordance with guidance given in the section on Food Additives and
Contaminants in the Relations between Commodity Committees and General
Committees, and may take the following form:
“The following provisions in respect of food additives and their
specifications as contained in section ........ of the Codex Alimentarius
are subject to endorsement [have been endorsed] by the Codex
Committee on Food Additives .”
Then should follow a tabulation, viz.:
“Name of additive, maximum level (in percentage or mg/kg).”
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Format for commodity standards
CONTAMINANTS
Pesticide Residues:
This section should include, by reference, any levels for pesticide residues that
have been established by the Codex Alimentarius Commission for the product
concerned. 21
Other Contaminants:
In addition, this section should contain the names of other contaminants and
where appropriate the maximum level permitted in the food, and the text to
appear in the standard may take the following form:
“The following provisions in respect of contaminants, other than
pesticide residues, are subject to endorsement [have been endorsed] by
the Codex Committee on Contaminants in Foods.”
Then should follow a tabulation, viz.:
“Name of contaminant, maximum level (in percentage or mg/kg).”
HYGIENE
Any specific mandatory hygiene provisions considered necessary should be
included in this section. They should be prepared in accordance with the
guidance given in the section on Food Hygiene in the Relations between
Commodity Committees and General Committees. Reference should also be
made to applicable codes of hygienic practice. Any parts of such codes,
including in particular any end-product specifications, should be set out in the
standard, if it is considered necessary that they should be made mandatory. The
following statement should also appear:
“The following provisions in respect of the food hygiene of this product
are subject to endorsement [have been endorsed] by the Codex
Committee on Food Hygiene.”
WEIGHTS AND MEASURES
This section should include all provisions, other than labelling provisions,
relating to weights and measures, e.g. where appropriate, fill of container,
weight, measure or count of units determined by an appropriate method of
sampling and analysis. Weights and measures should be expressed in S.I. units.
In the case of standards which include provisions for the sale of products in
21
N.B. This Procedure has not been followed for practical reasons. Codex
maximum limits for pesticide residues are published separately in Volume 2 of the Codex
Alimentarius.
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Format for commodity standards
standardized amounts, e.g. multiples of 100 grams, S.I. units should be used, but
this would not preclude additional statements in the standards of these
standardized amounts in approximately similar amounts in other systems of
weights and measures.
LABELLING
This section should include all the labelling provisions contained in the standard
and should be prepared in accordance with the guidance given in the section on
Food Labelling in the Relations between Commodity Committees and General
Committees. Provisions should be included by reference to the General
Standard for the Labelling of Prepackaged Foods. The section may also contain
provisions which are exemptions from, additions to, or which are necessary for
the interpretation of the General Standard in respect of the product concerned
provided that these can be justified fully. The following statement should also
appear:
“The following provisions in respect of the labelling of this product are
subject to endorsement [have been endorsed] by the Codex Committee
on Food Labelling.”
METHODS OF ANALYSIS AND SAMPLING
This section should include, either specifically or by reference, all methods of
analysis and sampling considered necessary and should be prepared in
accordance with the guidance given in the section on Methods of Analysis and
Sampling in the Relations between Commodity Committees and General
Committees. If two or more methods have been proved to be equivalent by the
Codex Committee on Methods of Analysis and Sampling, these could be
regarded as alternative and included in this section either specifically or by
reference. The following statement should also appear:
“The methods of analysis and sampling described hereunder are to be
endorsed [have been endorsed] by the Codex Committee on Methods of
Analysis and Sampling.” 22
22
Methods of analysis should be indicated as being “defining”, “reference”,
“alternative approved” or “tentative” methods, as appropriate.
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Relations between Committees
Codex Committees may ask the advice and guidance of committees having
responsibility for matters applicable to all foods on any points coming within
their province.
The Codex Committees on Food Labelling; Food Additives; Contaminants in
Foods; Methods of Analysis and Sampling; Food Hygiene; Nutrition and
Foods for Special Dietary Uses; and Food Import and Export Inspection and
Certification Systems may establish general provisions on matters within their
terms of reference. These provisions should only be incorporated into Codex
Commodity Standards by reference unless there is a need for doing otherwise.
Codex Commodity standards shall contain sections on hygiene, labelling and
methods of analysis and sampling and these sections should contain all of the
relevant provisions of the standard. Provisions of Codex General Standards,
Codes or Guidelines shall only be incorporated into Codex Commodity
Standards by reference unless there is a need for doing otherwise. Where Codex
Committees are of the opinion that the general provisions are not applicable to
one or more commodity standards, they may request the responsible
Committees to endorse deviations from the general provisions of the Codex
Alimentarius. Such requests should be fully justified and supported by available
scientific evidence and other relevant information. Sections on hygiene,
labelling, and methods of analysis and sampling which contain specific
provisions or provisions supplementing the Codex General Standards, Codes or
Guidelines shall be referred to the responsible Codex Committees at the most
suitable time during Steps 3, 4 and 5 of the Procedure for the Elaboration of
Codex Standards and Related Texts, though such reference should not be
allowed to delay the progress of the standard to the subsequent steps of the
Procedure.
Subject and commodity Committees should refer to the principles and
guidelines developed by the Codex Committee on Food Import and Export
Inspection and Certification Systems when developing provisions and/or
recommendations on inspection and certification and make any appropriate
amendments to the standards, guidelines and codes within the responsibility of
the individual committees at the earliest convenient time.
FOOD LABELLING
The provisions on food labelling should be included by reference to the Codex
General Standard for the Labelling of Prepackaged Foods (CODEX STAN 1-
1985). Exemptions from, or additions to, the General Standard which are
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Relations between Committees
23
Codex Committees should decide which provisions are to be included.
24
Codex Committees may decide that further information is required on the
container. In this regard, special attention should be given to the need for storage
instructions to be included on the container.
96
Relations between Committees
98
Relations between Committees
100
Procedural Manual Core functions of Contact Points
101
Risk Analysis Policy
SECTION III
Working Principles for Risk Analysis
Risk Analysis Principles Applied by the Codex Committee on Food
Additives and Contaminants
CCFAC Policy for Exposure Assessment of Contaminants and Toxins
in Foods or Food Groups
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Risk Analysis Policy
SCOPE
1. These principles for risk analysis are intended for application in the frame-
work of the Codex Alimentarius.
2. The objective of these Working Principles is to provide guidance to the
Codex Alimentarius Commission and the joint FAO/WHO expert bodies and
consultations, so that food safety and health aspects of Codex standards and
related texts are based on risk analysis.
3. Within the framework of the Codex Alimentarius Commission and its
procedures, the responsibility for providing advice on risk management lies with
the Commission and its subsidiary bodies (risk managers), while the respon-
sibility for risk assessment lies primarily with the joint FAO/WHO expert
bodies and consultations (risk assessors).
RISK ANALYSIS - GENERAL ASPECTS
4. The risk analysis used in Codex should be:
• applied consistently;
• open, transparent and documented;
• conducted in accordance with both the Statements of Principle
Concerning the Role of Science in the Codex Decision-Making Process
and the Extent to Which Other Factors are Taken into Account and the
Statements of Principle Relating to the Role of Food Safety Risk
Assessment 25 ; and
• evaluated and reviewed as appropriate in the light of newly generated
scientific data.
5. The risk analysis should follow a structured approach comprising the three
distinct but closely linked components of risk analysis (risk assessment, risk
management and risk communication) as defined by the Codex Alimentarius
Commission26, each component being integral to the overall risk analysis.
6. The three components of risk analysis should be documented fully and sys-
tematically in a transparent manner. While respecting legitimate concerns to
25
See Appendix: General Decisions of the Commission
26
See Definitions of Risk Analysis Terms Related to Food Safety.
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Risk Analysis Policy
27
For the purpose of the present document, the term “interested parties” refers to
“risk assessors, risk managers, consumers, industry, the academic community and, as
appropriate, other relevant parties and their representative organizations” (see definition
of “Risk Communication”)
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Risk Analysis Policy
parties. This procedure aims at ensuring that the risk assessment is systematic,
complete, unbiased and transparent.
15. The mandate given by risk managers to risk assessors should be as clear as
possible.
16. Where necessary, risk managers should ask risk assessors to evaluate the
potential changes in risk resulting from different risk management options.
RISK ASSESSMENT28
17. The scope and purpose of the particular risk assessment being carried out
should be clearly stated and in accordance with risk assessment policy. The out-
put form and possible alternative outputs of the risk assessment should be
defined
18. Experts responsible for risk assessment should be selected in a transparent
manner on the basis of their expertise, experience, and their independence with
regard to the interests involved. The procedures used to select these experts
should be documented including a public declaration of any potential conflict of
interest. This declaration should also identify and detail their individual exper-
tise, experience and independence. Expert bodies and consultations should
ensure effective participation of experts from different parts of the world, in-
cluding experts from developing countries.
19. Risk assessment should be conducted in accordance with the Statements of
Principle Relating to the Role of Food Safety Risk Assessment and should in-
corporate the four steps of the risk assessment, i.e. hazard identification, hazard
characterization, exposure assessment and risk characterization.
20. Risk assessment should be based on all available scientific data. It should
use available quantitative information to the greatest extent possible. Risk as-
sessment may also take into account qualitative information.
21. Risk assessment should take into account relevant production, storage and
handling practices used throughout the food chain including traditional practices,
methods of analysis, sampling and inspection and the prevalence of specific
adverse health effects.
22. Risk assessment should seek and incorporate relevant data from different
parts of the world, including that from developing countries. These data should
particularly include epidemiological surveillance data, analytical and exposure
data. Where relevant data are not available from developing countries, the
Commission should request that FAO/WHO initiate time-bound studies for this
28
Reference is made to the Statements of Principle Relating to the Role of Food
Safety Risk Assessment: See Appendix: General Decisions of the Commission.
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Risk Analysis Policy
29
For the purpose of these Principles, preliminary risk management activities are
taken to include: identification of a food safety problem; establishment of a risk profile;
ranking of the hazard for risk assessment and risk management priority; establishment of
risk assessment policy for the conduct of the risk assessment; commissioning of the risk
assessment; and consideration of the result of the risk assessment.
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Risk Analysis Policy
risk assessment, and taking into account, where appropriate, other legitimate
factors relevant for the health protection of consumers and for the promotion of
fair practices in food trade, in accordance with the Criteria for the Consideration
of the Other Factors Referred to in the Second Statement of Principles30.
29. The Codex Alimentarius Commission and its subsidiary bodies, acting as
risk managers in the context of these Working Principles, should ensure that the
conclusion of the risk assessment is presented before making final proposals or
decisions on the available risk management options, in particular in the setting
of standards or maximum levels, bearing in mind the guidance given in
paragraph 10.
30. In achieving agreed outcomes, risk management should take into account
relevant production, storage and handling practices used throughout the food
chain including traditional practices, methods of analysis, sampling and inspec-
tion, feasibility of enforcement and compliance, and the prevalence of specific
adverse health effects.
31. The risk management process should be transparent, consistent and fully
documented. Codex decisions and recommendations on risk management should
be documented, and where appropriate clearly identified in individual Codex
standards and related texts so as to facilitate a wider understanding of the risk
management process by all interested parties.
32. The outcome of the preliminary risk management activities and the risk
assessment should be combined with the evaluation of available risk manage-
ment options in order to reach a decision on management of the risk.
33. Risk management options should be assessed in terms of the scope and
purpose of risk analysis and the level of consumer health protection they
achieve. The option of not taking any action should also be considered.
34. In order to avoid unjustified trade barriers, risk management should ensure
transparency and consistency in the decision-making process in all cases.
Examination of the full range of risk management options should, as far as pos-
sible, take into account an assessment of their potential advantages and disad-
vantages. When making a choice among different risk management options,
which are equally effective in protecting the health of the consumer, the
Commission and its subsidiary bodies should seek and take into consideration
the potential impact of such measures on trade among its Member countries and
select measures that are no more trade-restrictive than necessary.
35. Risk management should take into account the economic consequences and
the feasibility of risk management options. Risk management should also recog-
30
See Appendix: General Decisions of the Commission.
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Risk Analysis Policy
the procedures followed to determine them, including how the uncertainty was
dealt with, should also be clearly explained. It should indicate any constraints,
uncertainties, assumptions and their impact on the risk analysis, and minority
opinions that had been expressed in the course of the risk assessment (see para.
25).
41. The guidance on risk communication in this document is addressed to all
those involved in carrying out risk analysis within the framework of Codex
Alimentarius. However, it is also of importance for this work to be made as
transparent and accessible as possible to those not directly engaged in the
process and other interested parties while respecting legitimate concerns to pre-
serve confidentiality (see para. 6).
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Risk Analysis Policy
SECTION 1. SCOPE
1) This document addresses the respective applications of risk analysis
principles by the Codex Committee on Food Additives and Contaminants
(CCFAC) and the Joint FAO/WHO Expert Committee on Food Additives
(JECFA). For matters which cannot be addressed by JECFA, this document
does not preclude the possible consideration of recommendations arising
from other internationally recognized expert bodies, as approved by the
Commission.
2) This document should be read in conjunction with the Working Principles
for Risk Analysis for Application in the Framework of the Codex
Alimentarius.
SECTION 2. CCFAC and JECFA
3) CCFAC and JECFA recognize that communication between risk assessors
and risk managers is critical to the success of their risk analysis activities.
4) CCFAC and JECFA should continue to develop procedures to enhance
communication between the two committees.
5) CCFAC and JECFA should ensure that their contributions to the risk
analysis process involve all interested parties and are fully transparent and
thoroughly documented. While respecting legitimate concerns to preserve
confidentiality, documentation should be made available, upon request, in a
timely manner to all interested parties.
6) JECFA, in consultation with CCFAC, should continue to explore
developing minimum quality criteria for data requirements necessary for
JECFA to perform risk assessments. These criteria are used by CCFAC in
preparing its Priority List for JECFA. The JECFA Secretariat should
consider whether these minimum quality criteria for data have been met
when preparing the provisional agenda for meetings of JECFA.
SECTION 3. CCFAC
7) CCFAC is primarily responsible for recommending risk management
proposals for adoption by the CAC.
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Risk Analysis Policy
31
A Safety Assessment is defined as a scientifically-based process consisting of:
1) the determination of a NOEL (No Observed Effect Level) for a chemical, biological,
or physical agent from animal feeding studies and other scientific considerations; 2) the
subsequent application of safety factors to establish an ADI or tolerable intake; and 3)
comparison of the ADI or tolerable intake with probable exposure to the agent
(Temporary definition to be modified when JECFA definition is available).
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16) CCFAC shall take into account differences in regional and national food
consumption patterns and dietary exposure as assessed by JECFA when
recommending maximum use levels for additives or maximum levels for
contaminants and naturally occurring toxicants in food.
17) Before finalising proposals for maximum levels for contaminants and
naturally occurring toxicants, CCFAC shall seek the scientific advice of
JECFA about the validity of the analysis and sampling aspects, about the
distribution of concentrations of contaminants and naturally occurring
toxicants in foods and about other relevant technical and scientific aspects,
including dietary exposure, as necessary to provide for a suitable scientific
basis for its advice to CCFAC.
18) When establishing its standards, codes of practice, and guidelines, CCFAC
shall clearly state when it applies any other legitimate factors relevant to the
health protection of consumers and to ensuring fair practices in food trade
in accordance with the Criteria for the Consideration of the Other Factors
Referred to in the Second Statement of Principles, in addition to JECFA’s
risk assessment, and specify its reasons for doing so.
19) CCFAC’s risk communication with JECFA includes prioritising substances
for JECFA review with the view towards obtaining the best available risk
assessment for purposes of elaborating safe conditions of use for food
additives and elaborating safe maximum levels or codes of practice for
contaminants and naturally occurring toxicants in food.
20) CCFAC shall consider the following when preparing its priority list of
substances for JECFA review:
− Consumer protection from the point of view of health and
prevention of unfair trade practices;
− CCFAC’s Terms of Reference;
− JECFA’s Terms of Reference;
− The Codex Alimentarius Commission’s Strategic Plan , its relevant
plans of work and Criteria for the Establishment of Work Priorities;
− The quality, quantity, adequacy, and availability of data pertinent to
performing a risk assessment, including data from developing
countries;
− The prospect of completing the work in a reasonable period of time;
− The diversity of national legislation and any apparent impediments
to international trade;
− The impact on international trade (i.e., magnitude of the problem in
international trade);
− The needs and concerns of developing countries; and,
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Risk Analysis Policy
30) JECFA should strive to base its risk assessments on global data, including
data from developing countries. These data should include epidemiological
surveillance data and exposure studies.
31) JECFA is responsible for evaluating exposure to additives, contaminants,
and naturally occurring toxicants.
32) When evaluating intake of additives or contaminants and naturally
occurring toxicants during its risk assessment, JECFA should take into
account regional differences in food consumption patterns.
33) JECFA should provide to CCFAC its scientific views on the validity and
the distribution aspects of the available data regarding contaminants and
naturally occurring toxicants in foods which have been used for exposure
assessments, and should give details on the magnitude of the contribution to
the exposure from specific foods as may be relevant for risk management
actions or options of CCFAC.
34) JECFA should communicate to CCFAC the magnitude and source of
uncertainties in its risk assessments. When communicating this information,
JECFA should provide CCFAC with a description of the methodology and
procedures by which JECFA estimated any uncertainty in its risk
assessment.
35) JECFA should communicate to CCFAC the basis for all assumptions used
in its risk assessments including default assumptions used to account for
uncertainties.
36) JECFA’s risk assessment output to CCFAC is limited to presenting its
deliberations and the conclusions of its risk assessments and safety
assessments in a complete and transparent manner. JECFA’s
communication of its risk assessments should not include the consequences
of its analyses on trade or other non-public health consequence. Should
JECFA include risk assessments of alternative risk management options,
JECFA should ensure that these are consistent with the Working Principles
for Risk Analysis for the Application in the Framework of the Codex
Alimentarius and Risk Analysis Principles applied by the Codex Committee
on Food Additives and Contaminants.
37) When establishing the agenda for a JECFA meeting, the JECFA Secretariat
work closely with CCFAC to ensure that CCFAC’s risk management
priorities are addressed in a timely manner. With respect to food additives,
the JECFA Secretariat should normally give first priority to compounds that
have been assigned a temporary ADI, or equivalent. Second priority should
normally be given to food additives or groups of additives that have
previously been evaluated and for which an ADI, or equivalent, has been
estimated, and for which new information is available. Third priority should
normally be given to food additives that have not been previously evaluated.
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SECTION 1. INTRODUCTION
1. Maximum Limits (MLs) do not need to be set for all foods that contain a
contaminant or a toxin. The Preamble of the Codex General Standard for
Contaminants and Toxins in Foods (GSCTF) states in Section 1.3.2 that
“maximum levels (MLs) shall only be set for those foods in which the
contaminant may be found in amounts that are significant for the total
exposure of the consumer. They should be set in such a way that the
consumer is adequately protected”. Setting standards for foods that
contribute little to dietary exposure would mandate enforcement activities
that do not contribute significantly to health outcomes.
2. Exposure assessment is one of the four components of risk assessment
within the risk analysis framework adopted by Codex as the basis for all
standard-setting processes. The estimated contribution of specific foods or
food groups to the total dietary exposure to a contaminant as it relates to a
quantitative health hazard endpoint (e.g., PMTDI, PTWI) provides further
information needed for the setting of priorities for the risk management of
specific foods/food groups. Exposure assessments must be guided by
clearly articulated policies elaborated by Codex with the aim of increasing
the transparency of risk management decisions.
3. The purpose of this Annex is to outline steps in contaminant data selection
and analysis undertaken by JECFA when requested by CCFAC to conduct a
dietary exposure assessment.
4. The following components highlight aspects of JECFA’s exposure
assessment of contaminants and toxins that contribute to ensuring
transparency and consistency of science-based risk assessments. Exposure
assessments of contaminants and toxins in foods are performed by JECFA
at the request of CCFAC. CCFAC will take this information into account
when considering risk management options and making recommendations
regarding contaminants and toxins in foods.
SECTION 2. ESTIMATION OF TOTAL DIETARY EXPOSURE TO A
CONTAMINANT OR TOXIN FROM FOODS/FOOD GROUPS
5. JECFA uses available data from member countries and from GEMS/Food
Operating Program for analytical laboratories system on contaminant levels
in foods and the amount of foods consumed to estimate total dietary
exposure to a contaminant or toxin. This is expressed as a percentage of the
116
Risk Analysis Policy
32
Rounded to the nearest 1/10th of a percent.
117
Risk Analysis Policy
119
Section IV Codex Alimentarius Commission
SECTION IV
Subsidiary Bodies
Membership
Organigram
120
Procedural Manual Commission sessions
(CX-701)33
SESSION PLACE AND DATES
1st Rome, Italy, 25 June - 3 July 1963
2nd Geneva, Switzerland, 28 September - 7 October 1964
3rd Rome, Italy, 19-28 October 1965
4th Rome, Italy, 7-14 November 1966
5th Rome, Italy, 20 February - 1 March 1968
6th Geneva, Switzerland, 4-14 March 1969
7th Rome, Italy, 7-17 April 1970
8th Geneva, Switzerland, 30 June - 9 July 1971
9th Rome, Italy, 6-17 November 1972
10th Rome, Italy, 1-11 July 1974
11th Rome, Italy, 29 March - 9 April 1976
12th Rome, Italy, 17-28 April 1978
13th Rome, Italy, 3-14 December 1979
14th Geneva, Switzerland, 29 June - 10 July 1981
15th Rome, Italy 4-15 July 1983
16th Geneva Switzerland, 1-12 July 1985
17th Rome, Italy, 29 June - 10 July 1987
18th Geneva, Switzerland, 3-12 July 1989
19th Rome, Italy, 1-10 July 1991
20th Geneva, Switzerland, 28 June - 7 July 1993
21st Rome, Italy, 3-8 July 1995
22nd Geneva, Switzerland, 23-28 June 1997
23rd Rome, Italy, 28 June - 3 July 1999
24th Geneva, Switzerland, 2-7 July 2001
25th Geneva, Switzerland, 13-15 February 200334
26th Rome, Italy, 30 June – 7 July 2003
27th Geneva, Switzerland, 28 June - 3 July 2004
28th Rome, Italy, 4-9 July 2005
29th Geneva, Switzerland, 3-7 July 2006
33
The reference code, followed by the number of the session, used in official
correspondence.
34
Extraordinary session.
121
Executive Committee sessions Codex Alimentarius Commission
(CX-702)
SESSION PLACE AND DATES
1st Rome, Italy, 3 July 1963
2nd Washington D.C., USA, 25-26 May 1964
3rd Geneva, Switzerland, 25-26 September 1964
4th Geneva, Switzerland, 7 October 1964
5th Rome, Italy, 3-4 June 1965
6th Rome, Italy, 18 October 1965
7th Rome, Italy, 28 October 1965
8th Rome, Italy, 14-16 June 1966
9th Rome, Italy, 4 November 1966
10th Rome, Italy, 16-18 May 1967
11th Rome, Italy, 19 February 1968
12th Rome, Italy, 5-7 June 1968
13th Geneva, Switzerland, 3 March 1969
14th Rome, Italy, 17-19 September 1969
15th Rome, Italy, 3 April 1970
16th Geneva, Switzerland, 9-11 February 1971
17th Geneva, Switzerland, 25 June 1971
18th Rome, Italy, 15-18 May 1972
19th Geneva, Switzerland, 3-5 July 1973
20th Rome, Italy, 28 June 1974
21st Geneva, Switzerland, 17-19 June 1975
22nd Rome, Italy, 23-24 March 1976
23rd Geneva, Switzerland, 12-15 July 1977
24th Rome, Italy, 13-14 April 1978
25th Geneva, Switzerland, 10-13 July 1979
26th Rome, Italy, 26-27 November 1979
27th Geneva, Switzerland, 13-17 October 1980
28th Geneva, Switzerland, 25-26 June 1981
29th Geneva, Switzerland, 12-16 July 1982
30th Rome, Italy, 30 June – 1 July 1983
31st Geneva, Switzerland, 25-29 June 1984
32nd Geneva, Switzerland, 27-28 June 1985
33rd Rome, Italy, 30 June – 4 July 1986
122
Procedural Manual Executive Committee sessions
35
Extraordinary session.
123
Subsidiary bodies
124
Subsidiary bodies
Terms of Reference:
To establish international codes and standards concerning milk and milk
products.
SUBSIDIARY BODIES UNDER RULE XI.1(b)(i)
CODEX COMMITTEE ON GENERAL PRINCIPLES (CX-716)
Host Government: France
Sessions:
1st Paris, 4-8 October 1965
2nd Paris, 16-19 October 1967
3rd Paris, 9-13 December 1968
4th Paris, 4-8 March 1974
5th Paris, 19-23 January 1976
6th Paris, 15-19 October 1979
7th Paris, 6-10 April 1981
8th Paris, 24-28 November 1986
9th Paris, 24-28 April 1989
10th Paris, 7-11 September 1992
11th Paris, 25-29 April 1994
12th Paris, 25-28 November 1996
13th Paris, 7-11 September 1998
14th Paris, 19-23 April 1999
15th Paris, 10-14 April 2000
16th Paris, 23-27 April 2001
17th Paris, 15-19 April 2002
18th Paris, 7-11 April 2003
19th Paris, 17–21 November 200336
20th Paris, 3-7 May 2004
21st Paris, 8-12 November 200436
22nd Paris, 11-15 April 2005
23rd Paris, 10-14 April 2006
Terms of Reference:
To deal with such procedural and general matters as are referred to it by the
Codex Alimentarius Commission. Such matters have included the
36
Extraordinary Session
125
Subsidiary bodies
establishment of the General Principles which define the purpose and scope of
the Codex Alimentarius, the nature of Codex standards and the forms of
acceptance by countries of Codex standards; the development of Guidelines for
Codex Committees; the development of a mechanism for examining any
economic impact statements submitted by governments concerning possible
implications for their economies of some of the individual standards or some of
the provisions thereof; the establishment of a Code of Ethics for the
International Trade in Food.
CODEX COMMITTEE ON FOOD ADDITIVES (CX-711)
Renamed as Codex Committee on Food Additives and Contaminants by the 17th
Session of the Commission; renamed again by the 29th Session of the
Commission as Codex Committee on Food Additives, due to the creation of a
Committee on Contaminants in Foods (CX-735)
Host Government: China (since 39th Session), Netherlands (1st to 38th
Sessions)
Sessions:
1st The Hague, 19-22 May 1964
2nd The Hague, 10-14 May 1965
3rd The Hague, 9-13 May 1966
4th The Hague, 11-15 September 1967
5th Arnhem, 18-22 March 1968
6th Arnhem, 15-22 October 1969
7th The Hague, 12-16 October, 1970
8th Wageningen, 29 May - 2 June 1972
9th Wageningen, 10-14 December 1973
10th The Hague, 2-7 June 1975
11th The Hague, 31 May - 6 June 1977
12th The Hague, 10-16 October 1978
13th The Hague, 11-17 September 1979
14th The Hague, 25 Nov. - 1 Dec. 1980
15th The Hague, 16-22 March 1982
16th The Hague, 22-28 March 1983
17th The Hague, 10-16 April 1984
18th The Hague, 5-11 November 1985
19th The Hague, 17-23 March 1987
20th The Hague, 7-12 March 1988
21st The Hague, 13-18 March 1989
22nd The Hague, 19-24 March 1990
23rd The Hague, 4-9 March 1991
24th The Hague, 23-28 March 1992
126
Subsidiary bodies
Terms of reference:
(a) to establish or endorse permitted maximum levels for individual food
additives;
(b) to prepare priority lists of food additives for risk assessment by the Joint
FAO/WHO Expert Committee on Food Additives;
(c) to assign functional classes to individual food additives;
(d) to recommend specifications of identity and purity for food additives for
adoption by the Commission;
(e) to consider methods of analysis for the determination of additives in food;
and
(f) to consider and elaborate standards or codes for related subjects such as
the labelling of food additives when sold as such.
Terms of reference:
(a) to draft basic provisions on food hygiene applicable to all food37;
(b) to consider, amend if necessary and endorse provisions on hygiene
prepared by Codex commodity committees and contained in Codex commodity
standards, and
(c) to consider, amend if necessary, and endorse provisions on hygiene
prepared by Codex commodity committees and contained in Codex codes of
practice unless, in specific cases, the Commission has decided otherwise, or
(d) to draft provisions on hygiene applicable to specific food items or food
groups, whether coming within the terms of reference of a Codex commodity
committee or not;
(e) to consider specific hygiene problems assigned to it by the Commission;
(f) to suggest and prioritize areas where there is a need for microbiological
risk assessment at the international level and to develop questions to be
addressed by the risk assessors;
(g) to consider microbiological risk management matters in relation to food
hygiene, including food irradiation, and in relation to the risk assessment of
FAO and WHO.
37
The term “hygiene” includes, where necessary, microbiological specifications
for food and associated methodology.
129
Subsidiary bodies
130
Subsidiary bodies
Terms of reference:
(a) to draft provisions on labelling applicable to all foods;
(b) to consider, amend if necessary, and endorse draft specific provisions on
labelling prepared by the Codex Committees drafting standards, codes of
practice and guidelines;
(c) to study specific labelling problems assigned to it by the Commission;
(d) to study problems associated with the advertisement of food with particular
reference to claims and misleading descriptions.
CODEX COMMITTEE ON METHODS OF ANALYSIS AND SAMPLING (CX-715)
Host Government: Hungary (since the 7th session), Federal Republic of
Germany (1st to 6th sessions)
Sessions:
1st Berlin, 23-24 September 1965
2nd Berlin, 20-23 September 1966
3rd Berlin, 24-27 October 1967
4th Berlin, 11-15 November 1968
5th Cologne, 1-6 December 1969
6th Bonn Bad Godesberg, 24-28 January 1971
7th Budapest, 12-18 September 1972
8th Budapest, 3-7 September 1973
9th Budapest, 27-31 October 1975
10th Budapest, 24-28 October 1977
11th Budapest, 2-6 July 1979
12th Budapest, 11-15 May 1981
13th Budapest, 29 November - 3 December 1982
14th Budapest, 26-30 November 1984
15th Budapest, 10-14 November 1986
16th Budapest, 14-19 November 1988
17th Budapest, 8-12 April 1991
18th Budapest, 9-13 November 1992
19th Budapest, 21-25 March 1994
20th Budapest, 2-6 October 1995
21st Budapest, 10-14 March 1997
22nd Budapest, 23-27 November 1998
23rd Budapest, 26 February – March 2001
24th Budapest, 18-22 November 2002
25th Budapest, 8-12 March 2004
131
Subsidiary bodies
Terms of reference:
(a) to define the criteria appropriate to Codex Methods of Analysis and
Sampling;
(b) to serve as a coordinating body for Codex with other international groups
working in methods of analysis and sampling and quality assurance systems for
laboratories;
(c) to specify, on the basis of final recommendations submitted to it by the
other bodies referred to in (b) above, Reference Methods of Analysis and
Sampling appropriate to Codex Standards which are generally applicable to a
number of foods;
(d) to consider, amend, if necessary, and endorse, as appropriate, methods of
analysis and sampling proposed by Codex (Commodity) Committees, except
that methods of analysis and sampling for residues of pesticides or veterinary
drugs in food, the assessment of micro biological quality and safety in food, and
the assessment of specifications for food additives, do not fall within the terms
of reference of this Committee;
(e) to elaborate sampling plans and procedures, as may be required;
(f) to consider specific sampling and analysis problems submitted to it by the
Commission or any of its Committees;
(g) to define procedures, protocols, guidelines or related texts for the
assessment of food laboratory proficiency, as well as quality assurance systems
for laboratories.
Terms of reference:
(a) to establish maximum limits for pesticide residues in specific food items or
in groups of food;
(b) to establish maximum limits for pesticide residues in certain animal
feeding stuffs moving in international trade where this is justified for reasons of
protection of human health;
133
Subsidiary bodies
(c) to prepare priority lists of pesticides for evaluation by the Joint FAO/WHO
Meeting on Pesticide Residues (JMPR);
(d) to consider methods of sampling and analysis for the determination of
pesticide residues in food and feed;
(e) to consider other matters in relation to the safety of food and feed
containing pesticide residues; and
(f) to establish maximum limits for environmental and industrial contaminants
showing chemical or other similarity to pesticides, in specific food items or
groups of food.
Terms of reference:
(a) to determine priorities for the consideration of residues of veterinary drugs
in foods;
(b) to recommend maximum levels of such substances;
134
Subsidiary bodies
Terms of reference:
(a) to develop principles and guidelines for food import and export inspection
and certification systems with a view to harmonising methods and procedures
which protect the health of consumers, ensure fair trading practices and
facilitate international trade in foodstuffs;
(b) to develop principles and guidelines for the application of measures by the
competent authorities of exporting and importing countries to provide assurance
where necessary that foodstuffs comply with requirements, especially statutory
health requirements;
135
Subsidiary bodies
38
Quality assurance means all those planned and systematic actions necessary to
provide adequate confidence that a product or service will satisfy given requirements for
quality (ISO-8402 Quality - Vocabulary)
136
Subsidiary bodies
Terms of reference:
(a) to study specific nutritional problems assigned to it by the Commission
and advise the Commission on general nutrition issues;
(b) to draft general provisions, as appropriate, concerning the nutritional
aspects of all foods;
(c) to develop standards, guidelines or related texts for foods for special
dietary uses, in cooperation with other committees where necessary;
(d) to consider, amend if necessary, and endorse provisions on nutritional
aspects proposed for inclusion Codex standards, guidelines and related texts.
Terms of reference:
To elaborate world wide standards for all types of processed fruits and
vegetables including dried products, canned dried peas and beans, jams and
jellies, but not dried prunes, or fruit and vegetable juices. The Commission has
also allocated to this Committee the work of revision of standards for quick
frozen fruits and vegetables.
Terms of reference:
To elaborate world wide standards for fats and oils of animal, vegetable and
marine origin including margarine and olive oil.
140
Subsidiary bodies
141
Subsidiary bodies
142
Subsidiary bodies
Terms of reference:
To elaborate world wide standards for fresh, frozen (including quick frozen) or
otherwise processed fish, crustaceans and molluscs.
143
Subsidiary bodies
Terms of reference:
To elaborate world wide standards for soups, broths, bouillons and consommés.
Terms of Reference:
(a) to elaborate world wide standards and codes of practice as may be
appropriate for fresh fruits and vegetables;
(b) to consult with the UNECE Working Party on Agricultural Quality
Standards in the elaboration of world wide standards and codes of practice with
particular regard to ensuring that there is no duplication of standards or codes of
practice and that they follow the same broad format39;
39
The Working Party on Agricultural Quality Standards of the United Nations
Economic Commission for Europe:
145
Subsidiary bodies
Terms of reference:
To elaborate world-wide standards, codes and related texts for milk and milk
products.
1. may recommend that a world wide Codex standard for fresh fruits and vegetables
should be elaborated and submit its recommendation either to the Codex Committee on
Fresh Fruits and Vegetables for consideration or to the Commission for approval;
2. may prepare “proposed draft standards” for fresh fruits or vegetables at the
request of the Codex Committee on Fresh Fruits and Vegetables or of the Commission
for distribution by the Codex Secretariat at Step 3 of the Codex Procedure, and for
further action by the Codex Committee on Fresh Fruits and Vegetables;
3. may wish to consider “proposed draft standards” and “draft standards” for fresh
fruits and vegetables and transmit comments on them to the Codex Committee on Fresh
Fruits and Vegetables at Steps 3 and 6 of the Codex Procedure; and
4. may perform specific tasks in relation to the elaboration of standards for fresh
fruits and vegetables at the request of the Codex Committee on Fresh Fruits and
Vegetables.
Codex “proposed draft standards” and “draft standards” for fresh fruits and
vegetables at Steps 3 and 6 of the Codex Procedure should be submitted to the UN/ECE
Secretariat for obtaining comments.
146
Subsidiary bodies
wide standards for natural mineral waters and bottled (packaged) water other
than natural mineral water.
Host Government: Switzerland
Sessions:
1st Baden, Aargau, 24-25 February 1966
2nd Montreux, 6-7 July 1967
3rd Bad Ragaz, - 9 May 1968
4th Vienna, 12-13 June 1972
5th Thun, 3-5 October 1996
6th Berne, 19-21 November 1998
7th Fribourg, 30 October – 1 November 2000
Adjourned sine die.
Terms of reference:
To elaborate regional standards for natural mineral waters.
Dissolved by the 28th Session of the Commission (2005) upon completion of its
mandate.
Terms of Reference:
The ad hoc Task Force shall:
(a) revise and consolidate the existing Codex standards and guidelines for fruit
and vegetable juices and related products, giving preference to general
standards;
147
Subsidiary bodies
(b) revise and up-date the methods of analysis and sampling for these
products;
(c) complete its work prior to the 28th Session of the Commission (2005).
148
Subsidiary bodies
Objectives (2004-)
To develop standards, guidelines or recommendations, as appropriate, for foods
derived from modern biotechnology or traits introduced into foods by modern
biotechnology, on the basis of scientific evidence, risk analysis and having
regard, where appropriate, to other legitimate factors relevant to the health of
consumers and the promotion of fair practices in the food trade.
Time frame (2004-)
The Task Force shall complete its work within four years. The Task Force
should submit a full report in 2009.
Terms of Reference (2004-)
(a) To elaborate standards, guidelines, or other principles, as appropriate, for
foods derived from modern biotechnology, taking account, in particular, of the
Principles for the Risk Analysis of Foods derived from Modern Biotechnology;
(b) To coordinate and closely collaborate, as necessary, with appropriate Codex
Committees within their mandate as relates to foods derived from modern
biotechnology; and
(c) To take account of existing work carried out by national authorities, FAO,
WHO, other international organizations and other relevant international fora.
Dissolved by the 27th Session of the Commission (2004) upon completion of its
mandate.
Objectives
With the aim of ensuring the safety and quality of foods of animal origin, the
Task Force should develop guidelines or standards as appropriate on Good
Animal Feeding practices.
149
Subsidiary bodies
Terms of Reference
(a) To complete and extend the work already done by relevant Codex
Committees on the Draft Code of Practice for Good Animal Feeding.
(b) To address other aspects which are important for food safety, such as
problems related to toxic substances, pathogens, microbial resistance, new
technologies, storage, control measures, traceability, etc.
(c) To take full account of and collaborate with, as appropriate, work carried
out by relevant Codex Committees, and other relevant international bodies,
including FAO, WHO, OIE and IPPC.
150
Subsidiary bodies
151
Subsidiary bodies
152
Subsidiary bodies
153
Subsidiary bodies
Terms of reference:
(a) defines the problems and needs of the region concerning food standards
and food control;
(b) promotes within the Committee contacts for the mutual exchange of
information on proposed regulatory initiatives and problems arising from food
control and stimulates the strengthening of food control infrastructures;
(c) recommends to the Commission the development of world wide standards
for products of interest to the region, including products considered by the
Committee to have an international market potential in the future;
(d) develops regional standards for food products moving exclusively or
almost exclusively in intra regional trade;
(e) draws the attention of the Commission to any aspects of the Commission’s
work of particular significance to the region;
(f) promotes coordination of all regional food standards work undertaken by
international governmental and non-governmental organizations within the
region;
(g) exercises a general coordinating role for the region and such other
functions as may be entrusted to it by the Commission;
(h) promotes the use of Codex standards and related texts by members.
Sessions:
1st Berne, 1-2 July 1965
2nd Rome, 20 October 1965
3rd Vienna, 24-27 May 1966
4th Rome, 8 November 1966
5th Vienna, 6-8 September 1967
6th Vienna, 4-8 November 1968
7th Vienna, 7-10 October 1969
8th Vienna, 27-29 October 1971
9th Vienna, 14-16 June 1972
10th Vienna, 13-17 June 1977
11th Innsbruck, 28 May - 1 June 1979
12th Innsbruck, 16-20 March 1981
13th Innsbruck, 27 September -1 October 1982
14th Thun, 4-8 June 1984
15th Thun, 16-20 June 1986
16th Vienna, 27 June - 1 July 1988
154
Subsidiary bodies
Sessions:
1st Rome, 25-26 March 1976
2nd Montevideo, 9-15 December 1980
3rd Havana, 27 March - 2 April 1984
4th Havana, 17-22 April 1985
5th Havana, 11-16 February 1987
6th San José, 20-24 February 1989
7th San José, 1-10 July 1991
8th Brasília, 16-20 March 1993
9th Brasília, 3-7 April 1995
10th Montevideo, 25-28 February 1997
11th Montevideo, 8-11 December 1998
12th Santo Domingo, 13-16 February 2001
13th Santo Domingo, 9-13 December 2002
14th Buenos Aires, 29 November-3 December 2004
15th Mar del Plata, 13-17 November 2006
156
Subsidiary bodies
157
Subsidiary bodies
(g) exercises a general coordinating role for the region and such other
functions as may be entrusted to it by the Commission;
(h) promotes the use of Codex standards and related texts by members.
Sessions:
1st Honolulu, 30 April - 4 May 1990
2nd Canberra, 2-6 December 1991
3rd Vancouver, 31 May - 3 June 1994
4th Rotorua, 30 April - 3 May 1996
5th Seattle, 6-9 October 1998
6th Perth, 5-8 December 2000
7th Vancouver, 29 October - 1 November 2002
8th Apia, Samoa, 19-22 October 2004
9th Apia, Samoa, 10-13 October 2006
40
These Joint UNECE/Codex Alimentarius groups of experts were not subsidiary
bodies under any specific rule of the Codex Alimentarius Commission but followed the
same procedure as Codex Commodity Committees for the elaboration of Codex
standards.
158
Subsidiary bodies
Abolished by the 23rd Session of the Commission (1999). The work of the Joint
Group of Experts was transferred to the Codex Committee on Processed Fruits
and Vegetables (see the Terms of Reference of that Committee).
Terms of reference:
The Joint UNECE/Codex Alimentarius Group of Experts on the Standardization
of Quick Frozen Foods will be responsible for the development of standards for
quick frozen foods in accordance with the General Principles of the Codex
Alimentarius. The Joint Group will be responsible for general considerations,
definitions, a framework of individual standards for quick frozen food products
and for the actual elaboration of standards for quick frozen food products not
specifically allotted by the Commission to another Codex Committee, such as
Fish and Fishery Products, Meat, Processed Meat and Poultry Products.
Standards drawn up by Codex commodity committees for quick frozen foods
should be in accordance with the general standard laid down by the Joint
ECE/Codex Alimentarius Group of Experts on the Standardization of Quick
Frozen Foods and should, at an appropriate stage, be referred to it for
coordination purposes.
Fruit Juices (CX-704)
Sessions:
1st Geneva, 6-10 April 1964
2nd Geneva, 29 March - 2 April 1965
3rd Geneva, 21-25 February 1966
4th Geneva, 10-14 April 1967
5th Rome, 25-29 March 1968
6th Geneva, 27-31 October 1969
7th Rome, 20-24 July 1970
8th Geneva, 8-12 March 1971
9th Rome, 20-24 March 1972
10th Geneva, 16-20 July 1973
11th Rome, 14-18 October 1974
12th Geneva, 19-23 July 1976
13th Geneva, 26-30 June 1978
14th Geneva, 9-13 June 1980
15th Rome, 8-12 February 1982
16th Geneva, 30 April - 4 May 1984
17th Rome, 26-30 May 1986
18th Geneva, 16-20 May 1988
159
Subsidiary bodies
41
The meeting was not a subsidiary body under any specific rule of the Codex
Alimentarius Commission but followed the same procedure as Codex Commodity
Committees for the elaboration of Codex standards.
160
Membership
161
Membership Codex Alimentarius Commission
MEMBER ORGANIZATION
1. European Community
163
Appendix: General Decisions
42
Decision of the 21st Session of the Commission, 1995.
43
Decision of the 24th Session of the Commission, 2001.
164
Appendix: General Decisions
44
Confusion should be avoided between justification of national measures under
the SPS and TBT Agreements and their validity at the international level.
45
According to the WTO principles, and taking into account the particular
provisions of the SPS and TBT Agreements.
165
Appendix: General Decisions
46
Decision of the 22nd Session of the Commission, 1997.
166
Appendix: General Decisions
The Codex Alimentarius Commission, desiring that every effort should be made
to reach agreement on the adoption or amendment of standards by consensus,
recommends the following measures to facilitate consensus:
• Refraining from submitting proposals in the step process where the
scientific basis is not well established on current data and, where
necessary, carry out further studies in order to clarify controversial
issues;
• Providing for thorough discussions and documentation of the issues at
meetings of the committees concerned;
• Organizing informal meetings of the parties concerned where
disagreements arise, provided that the objectives of any such meetings
are clearly defined by the Committee concerned and that participation
is open to all interest delegations and observers in order to preserve
transparency;
• Redefining, where possible, the scope of the subject matter being
considered for the elaboration of standards in order to cut out issues on
which consensus could not be reached;
• Providing that matters are not progressed from step to step until all
relevant concerns are taken into account and adequate compromises
worked out;
• Emphasizing to Committees and their Chairpersons that matters should
not be passed on to the Commission until such time as consensus has
been achieved at the technical level;
• Facilitating the increased involvement and participation of developing
countries.
_____________________________
47
Decision of the 26th Session of the Commission, 2003.
167
Joint FAO/WHO Food Standards Programme
Codex Alimentarius
Commission
General Principles Milk and Milk Products Foods derived from Africa
(France) (New Zealand) Biotechnology (Morocco)
(Japan)