RESTRICTEDWORLD TRADE
ORGANIZATIONG/SPS/W/104
20 March 2000
(00-1120)
Committee on Sanitary and Phytosanitary Measures
PROPOSED GUIDELINES TO FURTHER THE PRACTICAL
IMPLEMENTATION OF ARTICLE 5.5
Note by the Secretariat
The following guidelines are proposed for adoption by the Committee at its meeting of 21-
22 June 2000.
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INTRODUCTION
Article 5.5 of the SPS Agreement states that:
With the objective of achieving consistency in the application of the concept of
appropriate level of sanitary or phytosanitary protection against risks to human life or
health, or to animal and plant life or hea lth, each Member shall avoid arbitrary or
unjustifiable distinctions in the levels it considers to be appropriate in different
situations, if such distinctions result in discrimination or a di sguised restriction on
international trade.  Members shall coopera te in the Committee,  in accordance with
paragraphs 1, 2 and 3 of Article 12, to develop guidelines to further the practicalimplementation of this provision.  In devel oping the guidelines, the Committee shall take
into account all relevant factors, incl uding the exceptional character of human health
risks to which people voluntarily expose themselves.
The following guidelines are intended to provide assistance to Members in the practical
implementation of the provisions of Article 5.5 of the SPS Agreement.  These guidelines do not add to
nor detract from the existing rights and obligations of Members under the SPS Agreement nor any other
WTO Agreement.  These guidelines do not provide any legal interpretation or modification to the
Agreement itself.  The guidelines are without prej udice to the right of a Member to determine its
appropriate level of sanitary and phytosanitary prot ection against risks to human life or health, or to
animal and plant life or health.
1
The guidelines address the two elements within Article 5.5:  (1) the objective of achieving
consistency in the application of the concept of the appropriate level of protection and (2) the obligation
to avoid arbitrary or unjustifiable distinctions in th e levels considered appropriate if such distinctions
                                                     
1"Risk" in the context of the SPS Agreement refers to the likelihood that an adverse event (pest or
disease) will occur and the magnitude of the associated potential consequences  on plant or animal life or health
of the adverse event, or to the potential for adverse effects  on human or animal life or health from food-borne
risks.  See paragraph 4, Annex A of the Agreement.G/SPS/W/104
Page 2
result in discrimination or a disguised restriction on international trade.  The determination of the
appropriate level of protection is an element in th e decision-making process which logically precedes the
selection and use of one or more sanitary or phytosanitary measures.  The following guidelines therefore
address the application of the concept of the appropriate level of protection, and subsequently its
practical implementation.
The comments accompanying the guidelines are designed to facilitate understanding of the
guidelines through the provision of examples and fu rther clarifications.  These comments and examples
are purely illustrative and not intended to be exclusive or complete.
The guidelines will be reviewed periodically and revised as necessary by the SPS Committee in
the light of experience gained through the implemen tation of the Agreement, the use of the guidelines
themselves and any pertinent work done by the rele vant international standard-setting organizations.2
The Committee should undertake a first review of the guidelines within 36 months of their adoption by
the Committee and thereafter as the need arises.
A. APPLICATION OF THE CONCEPT OF THE APPROPRIATE LEVEL OF PROTECTION
A.1. A Member should indicate the level of protection which it considers to be appropriate with
respect to risks to human life or health, to animal  life or health or to plant life or health in a
sufficiently clear manner so as to permit examin ation of the extent to which any sanitary or
phytosanitary measure achieves that level.
Such an indication may be contained in a published statement or other text generally
available to interested parties.  The statement of the appropriate level of protection may
be qualitative or quantitative, and should se rve to guide its consistent implementation
over time, and also to increase the transparency of the sanitary or phytosanitary
regime.  Examples might include governm ent policy statements with regard to
appropriate levels of protection in response to certain risks, or documents on animal
health protection objectives or with respect to plant protection.  The use of quantitative
terms, where feasible, to describe the appropriate level of protection can facilitate the
identification of arbitrary or unjustified distinctions in levels deemed appropriate in
different situations.
A.2. A Member should, when determining an appropriate level of protection, either as an overall
policy objective or for a specific situation, consider:
• whether there is a difference between the level of protection under consideration and
levels already determined by the Member in different situations and, if so,
• whether these differences are arbitrary or unjustifiable, and, if so,
• whether they may result in discrimination or in a disguised restriction on international
trade.
The comparison of levels of protection in different situations requires the existence of
sufficient common elements to render th em comparable and must be performed on a
case-by-case basis.  In the case of protection of plant or animal life or health from pests
or disease, situations might be compared if they involve either the risk of entry,
establishment or spread of the same or a similar disease, or the risk of the same or
                                                     
2 As indicated in Annex A, paragraph 3.G/SPS/W/104
Page 3
similar associated potential biological and economic consequences.  In the case of
protection of human life or health from specific risks, i.e. food-borne risks, or of animal
life or health from risks arising from feedstuffs, situations involving the same type of
substance or pathogen, and/or the same type of adverse health effect, could be
compared to one another.
The determination of whether differences in appropriate levels of protection are
arbitrary or unjustifiable depends on the particular case and has to be determined on a
case-by-case basis.  The establishment of different levels of protection in the face of
similar risks in different situations may raise the question as to whether the differences
in the levels of protection are arbitrary or unjustifiable.
The determination of whether arbitrary or unjustifiable differences in levels of
protection established by a Member in different situations do in fact result in
discrimination or a disguised restriction on trade should be examined in the context of
the circumstances of each case, including the potential effects on international trade.
Although no precise definition of "discrimination or a disguised restriction oninternational trade" currently exists, cumulative occurrence of the following "warning
signals" could indicate the existence of discrimination or a disguised restriction on
trade:
• substantial differences in the levels of protection considered to be appropriate in
different situations;
• the existence of arbitrary or unjustifiable differences in the levels of protection
considered by a Member as appropriate in different situations;
• the absence of a scientific justification for a sanitary or phytosanitary measure
applied allegedly to achieve the appropriate level of protection, or the fact that a
measure is not based on a risk assessme nt as appropriate to the circumstances
(either because there is no risk assessment or because there is an insufficient risk
assessment).
A.3. A Member should establish clear and eff ective communication and information flows within
and between the authorities responsible for the determination of appropriate levels of protection.
An important element in seeking to ensure  that decisions on an appropriate level of
protection meet the provisions of Articl e 5.5 is information and communication.  The
authorities responsible for the preparation and implementation of such decisions
should be aware of relevant decisions taken by that Member in other cases, and
particularly in situations comparable to the one at hand.
A.4. To avoid arbitrary or unjustifiable differences in the level of protection a Member considers
to be appropriate in different situations, a Member should compare any proposed decision on the levelof protection in a particular situation with the level it has previously considered or is considering to be
appropriate in situations which contain sufficient common elements so as to render them comparable
with regard to human life or health, to animal  life or health, or to plant life or health.
It can be useful to compare a proposed appropriate level of protection with previous
decisions, including those that might have been taken in an ad hoc fashion, to ensure
that any differences in levels of protection applied in a similar situation are justifiable
and would not result in discrimination or a disguised restriction on international trade.G/SPS/W/104
Page 4
If differences are observed in comparable situations, either the proposed level may need
to be modified, or the level of protection previously determined may need to be revised
in light of the Member's current views on its appropriate level of protection, or a
combination of the two.
What a Member is comparing are the levels of protection against the risks posed by
potential hazards to human, animal or plant life or health.  Risk in the context of the
SPS Agreement refers to the likelihood that an adverse event (pest or disease) will
occur and the magnitude of the associated potential consequences on plant or animal
life or health of the adverse event, or to the potential for adverse effects on human or
animal life or health from food-borne risks.  (See paragraph 4, Annex A of the
Agreement .)  Accordingly, categorizing risks as "similar" must include a comparison of
both the relevant likelihood and the corresponding consequences.  To facilitate
comparison of levels of protection considered appropriate in different situations,
Members may wish to categorize the various risks they are examining into groups of
what they consider to be similar.  (See also the first comment to Guideline 2.)
The comparison of the levels of protection considered appropriate in one situation with
those considered appropriate in another situation can be facilitated if the potential
damage is expressed in common terms, whet her qualitative or quantitative.  Where
feasible, use of quantitative terms and/or common units can facilitate comparisons.
A.5. In determining a new or modified appropriate level of protection, a Member should review its
previous decisions regarding appropriate levels of protection in the light of the objectives and
obligations of Article 5.5, taking into account current decisions and developments.
In undertaking this review, a Member may wish to give priority to the review and
revision, as necessary, of those decisions which most substantially deviate from the
objectives and obligations of Article 5.5 and which may have the most negative impact
on international trade.
Unless changes are made at the same time to all its comparable decisions on
appropriate levels of protection, a Member may find it difficult to avoid (at least
temporary) unjustifiable differences in levels of protection.
A Member should review its previous decisions on appropriate levels of protection at
suitable intervals.
A.6. In determining a new or modified appropriate level of protection a Member may find it
helpful to examine any relevant international stan dards, guidelines or recommendations, or decisions
taken by other Members facing similar risks and situations.
Notwithstanding that it is the right of each Member to determine its appropriate level of
protection and that there is no obligation for a Member to harmonize its level of
protection with that of other Members, comparisons with the level of protection other
Members have considered appropriate when addressing similar risks and situations
may assist a Member in making its own decision.
Likewise, significant differences between the level of protection which would result from
the application of the relevant international standard, guideline or recommendation
and the level of protection which a Member is considering may prompt the Member to
re-consider its proposed level of protection.G/SPS/W/104
Page 5
A.7. A Member may consider seeking expert advice  to contribute to its decision-making process
with regard to the determination of a new or modified appropriate level of protection.   
Advice may be sought from recognized, qualified experts, and could include
commenting on any unjustifiable distinctions in levels of protection, potential
discriminatory trade effects or other aspects related to consistency in the application
of its appropriate level of protection. A Member may seek assistance from the
relevant international standard-setting organizations in identifying appropriate
experts.
A.8. A Member should clearly identify those situations which it considers justify its acceptance
exceptionally of a lower level of protection for human health specifically with respect to risks towhich people voluntarily expose themselves.
Reasons for a significant difference in a proposed or accepted level of protection for
human health may, in exceptional circumstances, include a risk which humans
voluntarily accept.  Such circumstances might arise with respect to traditional foodsor some other products for which consume rs knowingly accept a higher risk than that
generally considered to be appropriate for food products .
3
B. PRACTICAL IMPLEMENTATION OF THE CONCEPT OF AN APPROPRIATE LEVEL OF PROTECTION
The SPS Agreement does not contain explicit provisions which oblige a Member to determine
its appropriate level of protection, although there is an implicit obligation to do so.  In practice, and
for various reasons, Members are not always able to indicate precisely their appropriate level of
protection.  In such cases, the appropriate level of protection may be determined on the basis of the
level of protection reflected in the SPS measures in place.  Therefore, to further the practicalimplementation of this provision, the following guidelines address the selection and use of measures.
This is without prejudice to the other provisions of the SPS Agreement which relate to measures,
which the Committee may decide to address separately.
B.1. A Member should establish clear and eff ective communication and information flows within
and between the authorities responsible for the determination of appropriate levels of protection, and
those responsible for the selection and implementation of sanitary or phytosanitary measures designed
to achieve the appropriate level of protection.
Since the concept of appropriate level of protection is applied in practice through
sanitary or phytosanitary measures, communication and transparency between the
government authorities responsible for the selection and implementation of sanitary
or phytosanitary measures and those responsible for the determination of the ALOPis an important element in  enhancing consistency.
B.2. A Member should establish common approaches or consistent procedures for use by the
authorities assessing risks and evaluating the measures which might be applied to achieve the desired
levels of protection.  In particular, a common appr oach should be developed with respect to risks
                                                     
3 Examples which were identified during the negotiation of this provision include the consumption of
alcoholic beverages, or substantial consumption of some traditional foods such as smoked fish, or of varieties of
fish known to be toxic.G/SPS/W/104
Page 6
affecting human life or health, a common approach for consideration of risks to animal life or health,
and a common approach for risks to plant life or health.
Clearly identified, comprehensive and consistent procedures for assessing risks and for
evaluating measures to reduce risk to acceptable levels will assist a Member to be moreconsistent in the application of its appropriate level of protection.
What a Member is comparing are the measures against the risks posed by potential
hazards to human, animal or plant life or health.  Risk in the context of the SPS
Agreement refers to the likelihood that an adverse event (pest or disease) will occur
and the magnitude of the associated potential consequences on plant or animal life or
health of the adverse event, or to the potential for adverse effects on human or animal
life or health from food-borne risks.  (See paragraph 4, Annex A of the Agreement .)
Accordingly, categorizing risks as "similar " must include a comparison of both the
relevant likelihoods and the corresponding consequence.  To facilitate comparison of
levels of protection considered appropriate in different situations, Members may wish
to categorize the various hazards they are examining into groups of what they
consider to be similar.
To the extent possible, risk should be assessed using the principles and procedures
developed by the relevant international or ganizations, taking into account the nature of
the hazards in question.
B.3. A Member should compare any proposed measure intended to achieve the appropriate level of
protection in a particular situation with other sanitary or phytosanitary measures it has taken, or is
considering, with regard to human life or health, to animal life or health, and plant life or health in
situations which present sufficient common elements so as to render them comparable.
Since the concept of an appropriate level of protection is applied through the
selection and implementation of a sanitary or phytosanitary measure (or measures),
such a comparison can be useful to ensure the consistency of the proposed measure
with any previous measures designed to achieve the same level of protection in
situations which present sufficient common elements so as to render them
comparable.
B.4. A Member should routinely review existing measures applied to achieve its appropriate level
of protection in accordance with the objectives of guideline A.5, taking also into account currentdecisions and developments.
In undertaking this review, a Member may wish to give priority to the review and
revision, as necessary, of the measures applied to achieve the appropriate levels of
protection reviewed in accordance with guideline A.5.
B.5. In considering a measure to achieve an appropriate level of protection in a particular situation,
a Member should determine whether a relevant international standard, guideline or recommendation
exists, and if it does, whether adoption of it would achieve the Member's appropriate level of
protection.
Comparisons with the manner in which an international standard, guideline or
recommendation would address a particular risk may assist a Member in clarifying
its own decision.  Significant differences in the measure applied by a Member to
address assessed risk compared to the measures that would result from theG/SPS/W/104
Page 7
application of a relevant international standard, guideline or recommendation, may
encourage the Member to reconsider whether it is acting in accordance with its
obligations under the SPS Agreement.
B.6. In considering a proposed measure to achieve its appropriate level of protection in a particular
situation, a Member may find it helpful to examine measures applied by other Members facing similarrisks and situations.
Notwithstanding that there is no obligation for a Member to harmonize its measures
with those of other Members, significant differences in the measures applied by a
Member in order to address a particular risk compared to the measures applied by
other Members facing similar risks and situations, and in particular measures which
are less restrictive of trade, may prompt the Member to reconsider whether it is actingconsistently with its obligations under the SPS Agreement.  The Member should in
particular compare its proposed measure with those applied by other Members
seeking a similar level of  protection from risks.
B.7. A Member may consider seeking expert advice  on the selection and implementation of SPS
measures to achieve its appropriate level of protection.
Advice may be sought from recognized, qualified experts, and could include
commenting on any potential discriminatory trade effects arising from specific
sanitary and phytosanitary measures.  A Member may seek assistance from therelevant international standard-setting organizations in identifying appropriate
experts.
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