WORLD TRADE
ORGANIZATIONG/SPS/GEN/211
6 November 2000
(00-4689)
Committee on Sanitary and Phytosanitary Measures Original:  English/
French/Spanish
RELEVANT CODEX DOCUMENTS ON EQUIVALENCE
OF SANITARY MEASURES
Information submitted by the Codex Alimentarius Commission (Codex)
At its June 2000 meeting, the Committee agreed that discussions on equivalence of sanitary
and phytosanitary measures would continue at the next Committee meeting.  The Chairman requested
that the observer organizations provide any relevant information regarding their work on equivalence.
Members will find attached additional information provided by the Codex Alimentarius Commission.
_________G/SPS/GEN/211
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Agenda Item 6 CX/FICS 00/6 August 2000
JOINT FAO/WHO FOOD STANDARDS PROGRAMME
CODEX COMMITTEE ON FOOD IMPORT AND EXPORT INSPECTION
AND CERTIFICATION SYSTEMS
Ninth Session
Perth, Australia, 11 – 15 December 2000
PROPOSED DRAFT GUIDELINES ON THE JUDGEMENT OF EQUIVALENCE OF
SANITARY MEASURES ASSOCIATED WITH FOOD INSPECTION AND
CERTIFICATION SYSTEMS
(At step 3)
Governments and international organizations wishing to submit comments on the
following subject matter are invited to do so no later than 29 September 2000
to: Digby Gascoine, Director, Policy and International Division, Australian
Quarantine and Inspection Service, GPO Box 858, Canberra ACT, 2601 (fax:
61.2.6272.3103; E-mail: codex.contact@affa.gov.au), with a copy to the
Secretary, Joint FAO/WHO Food Standards Programme, FAO, Via delle Terme
di Caracalla, 00100 Rome, Italy (Fax No + 39.06.5705.4593; or  E-mail:
codex@fao.org).
BACKGROUND
1. The 8th Session (February 2000) of the Codex Committee on Food Import and Export Inspection
and Certification Systems (CCFICS)1 considered a discussion paper prepared by New Zealand, in
cooperation with Australia, Canada and the United States, which included a suggested framework for
determining equivalence of sanitary measures a ssociated with food inspection and certification
systems. The CCFICS supported the development of guidelines within the Codex step procedure and
requested New Zealand, with assistance from Argentina, Australia, Canada, France, Japan, Morocco,
the United States and the European Commission, to proceed with the development of Guidelines onthe Judgement of Equivalence of Sanitary Measures Associated with Food Inspection and
Certification Systems for circulation and comment at Step 3 prior to the 9
th Session of the CCFICS.
The CCFICS also noted that its work in this area would be drawn to the attention of other Codex
committees, including CCGP and CCFH.
2. The 15th Session (April 2000) of the Codex Committee on General Principles, in considering
the general aspects of the development and application of "food safety objectives", noted that the
CCFICS had decided to develop the Guidelines.2
3. The 47th Session of the Executive Committee (June 2000) approved the elaboration of
Guidelines for the Judgement of Equivalence of Sanitary Measures Associated with Food Inspection
and Certification Systems as new work at Step 1. The Executive Committee recognized the need todevelop guidelines for determining equivalence of food control systems, covering not only safety but
also quality and conformity.
3
                                                     
1 ALINORM 01/30, paras 62-65
2 ALINORM 01/33, para. 64
3 ALINORM 01/3, paras. 26, 43 and Appendix IIIG/SPS/GEN/211
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Current Status
4. The proposed draft G uidelines on the Judgement of Equivalence of Sanitary Measures
Associated with Food Inspection and Certification Systems  is attached for comment at Step 3. The
comments submitted will be considered by the Committee at its 9th Session when discussing the
attached proposed draft Guidelines at Step 4.G/SPS/GEN/211
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PROPOSED DRAFT GUIDELINES ON THE JUDGEMENT OF EQUIVALENCE OF
SANITARY MEASURES ASSOCIATED WITH FOOD INSPECTION AND
CERTIFICATION SYSTEMS
(At step 3)
(Paper prepared by New Zealand with the assistance of Argentina, Australia, Canada
France, Japan, the United States and the European Union)
PREAMBLE
1. It is often the case that importing and exporting countries operate different food inspection
and certification systems.  The reasons for such differences include differences in prevalence of
particular food safety hazards, national choice about management of food safety risks and differencesin the historical development of food control systems.
2. In such circumstances, and in order to facili tate trade, there is a need to determine the
effectiveness of sanitary measures of the exporting country in achieving the appropriate level of
protection (ALOP) of the importing country.  This has led to recognition of the principle of
equivalence.
4
3. Application of the principle of equivalence has mutual benefits for both exporting and
importing countries.
SCOPE
4. This document provides guidelines for judgement of the equivalence of sanitary measures,
applied for the protection of human health, in international trade in foods.  For the purpose of
determining equivalence, the sanitary measures associated with a food inspection and certification
system can be broadly characterized as: infrastructure, programme design/implementation, and/or
specific requirements (refer paragraph 7).
DEFINITIONS
5. The definitions presented in this document are based on those of Codex and the WTO SPS
Agreement.
Sanitary measure:
Any measure applied to protect human health within the territory of the country from risks arising
from additives, contaminants, toxins or disease-causing organisms in food [or feedstuffs].
Hazard:
A biological, chemical or physica l agent in, or condition of, food with the potential to cause an
adverse health effect. 5
                                                     
4 World Trade Organization Agreement on the Appli cation of Sanitary and Phytosanitary Measures.
5 CAC Procedural Manual (11th Edition), pages 48-49.G/SPS/GEN/211
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Risk management:
The process, distinct from risk assessment, of we ighing policy alternatives, in consultation with all
interested parties, considering risk assessment and other factors relevant to the health protection of
consumers and for the promotion of fair trade practices, and, if needed, selecting appropriateprevention and control options.
2
Risk Assessment:
A scientifically-based process consisting of the following steps: (i) hazard identification; (ii) hazard
characterisation; (iii) exposure assessment; and (iv) risk characterisation.2
Appropriate level of protection:
The level of protection deemed appropriate by the country establishing a sanitary measure to protect
human health within its territory, which can be expressed in qualitative or quantitative terms.  [This
can otherwise be referred to as the "acceptable level of risk".]
Equivalence:
Equivalence is the state wherein sanitary measures applied in an exporting country, though different
from the measures applied in an importing country, achieve, [as demonstrated by the exportingcountry,] the importing country’s ALOP.
[SANITARY MEASURES INVOLVED IN THE DETERMINATION OF
EQUIVALENCE]
6. To facilitate judgement of equivalence between countries and promote harmonisation of food
safety standards, Codex members are encouraged to base their sanitary measures on Codex standards
and related texts.
7. Sanitary measures include all relevant laws, decrees, regulations, requirements and
procedures including, inter alia , end product criteria; processes and production methods; testing,
inspection, certification and approval procedures; provisions on relevant statistical methods, sampling
procedures and methods of risk assessment; and packaging and labelling requirements directly relatedto food safety.  For the purposes of determining equivalence, the sanitary measures associated with a
food inspection and certification system can be broadly categorised as:
(a) infrastructure; including the legislative base (e.g. food and enforcement law), and
administrative systems (e.g. organisation of national and regional authorities);
(b) programme (design/implementation/monitoring); including documentation of
systems, monitoring, performance, decision criteria and action, laboratory capability,
and provisions for certification and audit;  and/or
(c) specific requirements; including individual facilities (e.g. premises design),
equipment (e.g. design of food contact machinery), processes (e.g. HACCP plans),
procedures (e.g. ante and post mortem inspection) and tests (e.g. laboratory tests formicrobiological and chemical hazards).
8. A sanitary measure proposed for determination of equivalence may fall into one or more of
these categories, which are not mutually exclusive.  A single measure, however, on which anG/SPS/GEN/211
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equivalence determination may be made, cannot be considered in a vacuum.  In other words, whether
the importing country’s ALOP is likely to be achieved can only be determined in most cases through
an evaluation of all relevant components of an exporting country's food inspection and certification
system.  For example, a determination of equivalence for a specific sanitary measure at the
programme (design/implementation/monitoring) level will require a prior determination of an
equivalent infrastructure.  A determination of equivalence for a specific sanitary measure at thespecific requirements level will require a prior determination of an equivalent infrastructure, and
equivalent programme (design/implementation/monitoring).
9. An objective basis for comparison of sanitary measures must be established to allow an
equivalence determination to be made, and this may include the following elements:
(a) the reason/purpose for the sanitary measure(s);
(b) the relationship of the sanitary measure(s) to the ALOP;
(c) where appropriate, an expression of the level of control of the hazard(s) in a food that
is achieved by the sanitary measure(s) [in relation to other Codex activities, this may
be referred to as a "food safety objective"];
(d) where appropriate and available, risk assessment information relevant to the sanitary
measures under consideration.
GENERAL PRINCIPLES FOR DETERMINATION [DEMONSTRATION] OF
EQUIVALENCE
10. Determination of the equivalence of sanitary measures associated with food inspection and
certification systems should be based on application of the following principles:
10.1 An exporting country should recognise that an importing country has the sovereign right
to set a level of protection they deem appropriate in relation to their food supply.
6
[10.2 An importing country should be able to describe how its sanitary measure achieves, or
contributes to the achievement of, its ALOP.]
10.3 An importing should recognise that sanitary measures different from its own may be
capable of achieving its ALOP, and are therefore equivalent7.
10.4 The sanitary measures applied by the exporting country must meet the importing
country’s ALOP.
10.5 Countries should, upon request, enter into consultations with the aim of achieving
bilateral or multilateral recognition of the equivalence of specified sanitary measures8.
10.6 It is the responsibility of the exporting country to demonstrate that its sanitary measures
can meet the importing country’s ALOP.
10.7 The comparison of countries’ sanitary measures should be carried out in an objective
manner.
                                                     
6 Rights and obligations as recognised in the SPS agreement.
7 Principles of Food Import and Export Inspection and Certification; CAC/GL 20 – 1995.
8 Guidelines for the Design, Operation, Assessment and Accreditation of Food Import and Export
Inspection and Certification Systems CAC/GL 26- 1997.G/SPS/GEN/211
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[10.8 Where risk assessment is used in the demonstration of equivalence, countries should
strive to achieve consistency in the techniques applied so as to ensure that findings can
be objectively compared.]
[10.9 During equivalence discussions, an importing country should not unjustifiably impose
more stringent sanitary measures than those already specified.]
10.10 When judging the equivalence of sanitary measures, the importing country should take
into account any experience already gained in terms of food inspection and certification
systems in the exporting country.
10.11 Countries should strive for transparency in both the demonstration and judgement of 
equivalence.
GUIDELINES FOR THE DETERMINATION [ASSESSMENT] OF EQUIVALENCE
11. Determination of equivalence presumes that the exporting country has already reviewed all
applicable importing country sanitary measures for the food involved, and has identified those it willmeet and those for which it seeks a determination of equivalence.
12. The exporting and importing countries should co-operate in the determination of equivalence
by progressing through a series of steps.
13. The exporting country should present a submission for equivalence that facilitates the
judgement process applied by the importing country.  [Where achievement of equivalence is agreedupon by the importing country, the importing and exporting countries may enter into a formal
agreement giving effect to that decision.]
14. Importing and exporting countries should utilize an agreed process for exchange of
information.  This information should be limited to that which is necessary to facilitate the
determination of equivalence, and minimize administrative burden.
Steps
15. Determination of equivalence presumes that the exporting country has already reviewed all
applicable importing country sanitary measures for the food involved, and has identified those it will
meet and those for which it seeks a determination of equivalence.
16. The determination of equivalence is facilitated by both exporting and importing countries
following a sequence of steps, such as those described below and illustrated in Figure 1:
16.1 The exporting country identifies the sanitary measure(s) of the importing country for
which it wishes to apply a different measure, and requests the reason/purpose for the
measure(s).
16.2 The importing country provides the reason/purpose for the identified sanitary measure(s).16.3 On the initiative of the exporting country, the importing and exporting countries should
enter into a dialogue with a view to agree on an objective basis for comparison.G/SPS/GEN/211
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16.4 The exporting country develops the submission to demonstrate that the application of the
different sanitary measure(s) achieves or contributes to the achievement of the ALOP of
the importing country, and presents it to the importing country.9
16.5 If the importing country has any concerns with the submission as presented, it should
notify the exporting country at the earliest opportunity and should detail the reasons forconcern.  If possible, the importing country should suggest how the concerns might be
addressed.
16.6 The exporting country should respond to such concerns by providing further information
as appropriate.
16.7 The importing country notifies the exporting country of its judgement within a
reasonable period of time and provides the reasoning for its decision, should the
judgement be that the sanitary measure(s) is not equivalent.
16.8 An attempt may be made to resolve any differences of opinion over judgement of a
submission, either interim or final, including its timeliness, by using an agreedmechanism to reach consensus.
Judgement
17. Judgement of equivalence by the importing country should be based on an analytical process
that is objective and consistent, and should involve all interested parties to the extent practicable and
reasonable.
18. Where countries already have extensive experience and detailed knowledge of each other’s
food inspection and certification systems, at the time that an exporting country initiates a
determination of equivalence, a sanitary measure categorized as a specific requirement should be ableto be judged equivalent without consideration of the supporting programme
(design/implementation/monitoring) and infrastructure (refer paragraph 7).
19. Where countries do not already have extensive experience and detailed knowledge of each
other’s food inspection and certification systems, all categories of sanitary measures applicable to the
product or group of products under consideration need to be taken into account in the determination of
equivalence.  If the exporting and the importing country have no previous history of significant
trading in foods or detailed knowledge of each other’s food inspection and certification systems, thisprocess may require a detailed side-by-side comparison of all relevant sanitary measures.
20. Judgement of equivalence should take into account those Codex texts relevant to the food
safety matters under consideration.
21. Judgement of the equivalence of sanitary measures should take into account:
− supporting data submitted by the exporting country;
− analysis of the strength of the relationship between the exporting country’s specified
sanitary measure, alone or in conjunction with other sanitary measures, and the
achievement of the ALOP of the importing country;
− provision of objective parameters that have been given quantitative expression to the
maximum extent possible;
                                                     
9 CCFICS  Guidelines for the Development of Equivalence Agreements Regarding Food Import and
Export Inspection and Certification Systems; CAC/GL 34-1999.G/SPS/GEN/211
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− adequacy of qualitative descriptions where the level of control of hazards in foods in
not quantified;
− consideration of uncertainty in quantitative data;
− reference to Codex risk assessment methodologies where available, if risk
assessments are presented;
− consideration of all expected human health effects of the exporting country’s
identified sanitary measure(s).10
22. Following any judgement of equivalence, exporting and importing countries should advise
each other of significant changes in their supporting programmes and infrastructure that may affect
the original determination of equivalence.
                                                     
10 Consideration should be given to the effects of the sanitary measure on all hazards that may have
been identified during development of the case for equiva lence.  With regard to hazards not specified in the
reason/purpose provided, an identified sanitary measure ma y be shown to have an unintended adverse effect, or
an alternative sanitary measure may be shown to have a beneficial effect.G/SPS/GEN/211
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Figure I: Flow chart for the determination of equivalence
Request reason/purpose of the
sanitary measure(s)
Enter dialogue on objective
basis for com parison
No
Develop case for alternative
sanitary measure(s)Provide reason/purpose of the
sanitar y measure (s)
Dialogue
List
concerns
Evaluation
Equivalent?
Yes
STOPNo
CASE REJECTEDIdentify sanitary measure(s)
Alternative sanitary measure(s):
further develop case taking intoaccount of importing country concernsImporting country Exporting country
Evaluation
Equivalent?
Yes
STOPYes
Mechanism for possible resolution of different
opinions on case for equivalence
__________