WORLD TRADE
ORGANIZATIONG/SPS/GEN/94
24 September 1998
(98-3685)
Committee on Sanitary and Phytosanitary Measures Original:  English
INTERNATIONAL HARMONISATION OF SPS STANDARDS
Submission by India
1. The Agreement on the Application of Sanitary and Phytosanitary Measures (the "SPS
Agreement") desires to further the use of harmonised sanitary and phytosanitary measures between
Members on the basis of international standards, guidelines and recommendations developed by the
relevant international organizations, e.g., th e Codex Alimentarius Commission, the Office
international des épizooties, and international a nd regional organizations operating within the
framework of the International Plant Protection Convention.  Article 3.1, in particular, states that:
"To harmonize sanitary and phytosanitary measures on as wide a basis as possible,
Members shall base their sanitary or phytosanitary measures on international
standards, guidelines or recommendations, where they exist, except as otherwise
provided for in this Agreement, and in particular in paragraph 3."
Article 12.4 adds that:
The Committee [on Sanitary and Phytosanitary Measures] shall develop a procedure to
monitor the process of international harmonization and the use of international standards,guidelines or recommendations.
2. It is clear that the SPS Agreement requires Members to base their technical and SPS
regulations on international standards, guidelines or recommendations. In order to encourage
countries to use such international standards in their regulations, the SPS Agreement provides thatnational regulations which conform to international standards shall be presumed not to be barriers to
trade.  However, even though the SPS Agreement lays considerable emphasis on countries using
international standards in their SPS regulations, curiously enough, the SPS Agreement does not define
in precise terms when a standard should be considered as an international standard.  The criteria
adopted for determining an international standard is rather general and broad-based.  All standards,guidelines and recommendations developed by an international standardizing body or system are
required to be treated as an international standard and a standardizing body has been simply defined to
be international if its membership is open to "at l east all Members of WTO".  It is therefore clear that
in the absence of a precise definition of an international standard, a standard adopted by the
standardizing bodies is deemed to be an  "international standard", even if only a limited number of
countries may have participated in the technical work on developing the standard, and even if it may
have been adopted, not by consensus, but by a slender majority vote.
3. Despite the efforts that are being made by some of the international organizations to
encourage and broaden the participation of countries in standardization activities, the participation of
developing countries in the activities of these organizations continues to be marginal. Only a few
developing countries are able to participate activel y in the meetings of the technical committees.  The
majority of developing countries, even if present, are unable to participate effectively, since they areG/SPS/GEN/94
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not backed by background research that is needed for the submission of the technical papers. The
system of giving the responsibility for organizing the technical work to host countries, which provide
secretarial facilities, further puts developing countries in a disadvantageous situation.  Because of
various constraints they are not always in a position to offer such facilities and, therefore, cannot
effectively participate in the technical work.   It remains a matter of concern that most developing
countries have been unable to actively and effectively participate in the meetings of the internationalstandard setting bodies.   Their written comments are also often not given due weight which at times
leads to the adoption of standards which are not in consonance with the ground realities in most
developing countries.
4. Further, due to the non-participation of developing countries in the proceedings of various
international organizations engaged in standardisation, standards get fixed by default.  In view of this,
there is an urgent need to rationalise the procedure of standardisation activities presently followed by
these organizations and to make them more broad-based and representative so as to give adequateconsideration to the views of the developing and least developed countries.
5. It needs no emphasis that 89% of the countries of the world fall in the category of
developing/least developed countries.  In spite of this, various committees or expert groups, based on
a majority decision of the countries attending the meetings of these bodies, adopt international
standards.  In the absence of most developing countries, these meetings are naturally steered bydeveloped countries and very often the safety limits which are decided by these bodies are those
which are felt to be appropriate by the developed countries, without necessarily taking into
consideration the conditions prevailing in the developing countries.  Consequently, the developing
and least developed countries find it difficult to comply with sanitary measures that are based on such
standards, particularly since the safety limits in many cases are prescribed without conducting anyclinical study in the developing countries with rega rd to contaminants, pesticides, animal disease etc.
6. Moreover, given the diverse conditions prevailing in the developed and the developing
countries, it may be more appropriate to harmonise standards of a particular region where similar
conditions prevail and where the population also has more or less similar immunity levels.  Presently,
all regions do not have duly harmonised regional standards, which should be encouraged so as tofacilitate the setting up of international standards.  Since it is felt that these regional standards play a
vital role for the determination of international st andards, the international organizations engaged in
standardisation activities should take due note of these regional standards at the time of fixing the
international standard so as to give a much wider representation than exists currently.
7. In India’s view, the international standards formulation procedures followed by different
international organizations should have uniformity.  Presently, there are two major international
organizations in the area of standards for foods, namely, the International Organization for
Standardisation (the "ISO") and the Codex A limentarius Commission (the "Codex").  These
organizations are following different standards formulation procedures.  The procedures followed by
the ISO involve voting by letter ballot in which all members have an equal vote.  In the Codex, the
decision on acceptance of standards is on the basis of the decision taken at its meetings in which the
extent of participation of developing countries is uncertain as discussed above. Therefore, it needs tobe ensured that standards formulation procedures are harmonised at the international level.
8. The recent experience of the working of international standardizing organizations further
shows that it is becoming increasingly difficult even for countries that participate in such work to
adopt standards by consensus.  Until a few years back, decisions were generally made by consensus.
In fact, some of the definitions of international st andards even stated that they had been adopted by
consensus. This is no longer true and in some organizations like the Codex, more and more standards
are being adopted not through consensus but by a majority vote.  Though theoretically it may be
difficult to argue against the practicalities of such a modality, it has without doubt lead to a situationG/SPS/GEN/94
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where a number of standards are being adopted even though a sizeable number of countries have
opposed their adoption.  For instance, in the specific case of  natural mineral water, the standard was
ultimately adopted with 33 countries voting in favour and 31 voting against. This in effect meant that
a standard, which had the support of only about one-fifth of the total number of Members, was
adopted.  This is particularly disconcerting in the light of the fact that these meetings are as it is, often
attended by only a certain percentage of the Membership.
9. The involvement of international organizations in developing standards that are to be applied
on a mandatory basis has resulted in the increased interest of groups and lobbies in the standardising
work.   Governmental participation has become more direct, not least to ensure that the adoption of
the standards does not result in governments having to change existing regulations or to accept
standards which may be more stringent than their national standards, and there is simultaneously a
greater involvement of the business community and environmental groups.  This interest from non-
scientific bodies could result in the evolution of standards that may not be based solely on scientificevidence but could also reflect certain non-scientific considerations. This possible politicization of
standardisation activities can have serious ramifications on the role of science in the formulation and
adoption of international standards.  There is, therefore, a felt need to adopt a more precise and
stringent definition of international standards, and to ensure that these are based on empirical
scientific evidence alone.
10. A solution to some of the issues which arise from these recent developments in
standardisation activities, as well as those that arise from the ineffectual participation of developing
countries in these activities, could perhaps be found by adopting a more precise definition of
international standards, particularly those that are to be used as a basis for technical and SPS
measures.  For instance, international standards could be distinguished according to whether they arebeing developed for being used on a voluntary or a mandatory basis.  The existing definition which
states that all standards prepared by international standardisation bodies should be treated as
international standards could be applied to standards which are to be used on a voluntary basis.  For
standards that are developed with a possible view of adopting them on a mandatory basis, a narrower
definition could be adopted. Such a narrower definition could provide that for the purpose of the SPSAgreement, a standard, guideline or recommendation shall be considered mandatory only if an agreed
minimum number of countries from different regions have participated in its formulation, i.e., in the
entire process relating to its adoption, and that it has been adopted by consensus.
11. The advantages of such an approach are twofold.  Firstly, the obligation under the SPS
Agreement to use, to the maximum extent possible, an existing international standard would then be arealistic obligation since the standard would have been adopted by consensus. This would greatly
improve the compliance of the obligation and also reduce the possible conflicts which otherwise so
often arise when international standards are found to be far more stringent than existing national
standards. It would be indeed unrealistic to expect that the governments of countries which have voted
for the adoption of an international standard when it was being adopted, would subsequently have a
problem in adopting it as part of their national regulation.  Secondly, such a methodology would also
ensure that there is  wider participation in the work on formulation of standards since the countrieshaving trade interests in the standard/product  would actively and effectively participate in the
deliberations of the concerned international standardisation organization.
12. India would, accordingly, like to make the following suggestions:
(i) The SPS Committee should evaluate what steps have been taken by the international
standardising bodies to ensure effective participation of developing country Membersin the adoption of standards. This is perhaps the most crucial issue to be addressed in
the context of international harmonisation, since a large number of developing
countries feel that they have been sidelined in the standardisation process and that as aG/SPS/GEN/94
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consequence, standards which invariably restrict their market access are adopted by
these bodies.
(ii) It should also be examined whether due care has been taken of the capacity of
developing country Members to prepare and adopt international standards, guidelines
or recommendations which accommodate their development and trade needs and are
compatible with their prevailing level of technological and socio-economicdevelopment and trade.  This would facilitate the harmonization of international
standards with their national standards and thereby minimize the possible conflict
between international and nationally acceptable standards.  One way of doing this
could be by inviting representatives of international standardizing bodies to make
written and oral presentations to the Committee with a view to assessing whether and
in what way account is being taken of the special problems of developing countries.
(iii) Lack of transparency in the procedures of the three sister organizations is another
constraint in the fulfilment of obligations by Members under the SPS Agreement.  It
has been noted by India in various meetings of the Codex that, in order to reflect the
views of all Members of the Codex, there is need for inclusion of a voting procedure,
with voting being undertaken at both the dr aft and approval stages.  This would be in
line with the procedure followed by the ISO and the IEC.  The underlying problemwould be automatically mitigated if consensus-based decision making were adopted.
(iv) There is need to specify the basic definiti on of an international standard and to clarify
the weight given by the international standardising bodies to their recommendations
and standards.  Whereas Article 3.1 of the SPS Agreement does not differentiate
between guidelines and recommendations vis-a-vis standards, the standardisingbodies themselves do not treat them on par.   Hence, as elaborated in paragraph 10
above, the Committee could consider adopting a separate definition for standards,
depending on whether they are proposed to be adopted on a voluntary or a mandatory
basis.
(v) The process of harmonisation of national standards with international standards, to be
universally acceptable to Members, has to ensure that in the formulation of
international standards, the basic principles of the SPS Agreement are not lost sight
of.  Some core principles are enunciated in Article 5 of the SPS Agreement.
Article 5:4 states that "Members should, when determining the appropriate level of
sanitary or phytosanitary protection, take into account the objective of minimisingnegative trade effects".   Article 5:6 states that:  "Members shall ensure that such
measures are not more trade-restrictive than required to achieve their appropriate level
of sanitary or phytosanitary protection, taking into account technical and economic
feasibility".  These principles need to be integrated into the process of standard
formulation by the international standardising bodies if the standards formulated by
them are to gain acceptability of the majo rity of the WTO Members, with their wide
divergence of capabilities in processing technologies and perception of risk.
13. In view of the foregoing, while it is desirable, as per the SPS Agreement, to achieve
harmonisation on as wide a basis as possible by conforming to international standards, doubts arise as
to the "representativeness" of such standards.  The developing countries, in particular, are directly
affected by such partisan and impractical standards, since they not only restrict market access, thereby
acting as non-tariff barriers, but also involve high costs of achieving impractical and unrealisticstandards.  We would reiterate that special dispensation for developing countries envisaged in the SPS
Agreement should be translated into reality by Members.  This could be given effect to not only by
providing a longer transitional period so as to enable the developing and least developed countries toG/SPS/GEN/94
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integrate themselves effectively into the multilateral trading system, but also by providing them with a
level playing field through adequate technical assistance on fair and reasonable terms.
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