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International harmonization in
the SPS Agreement, an
overview
Rolando Alcala
Agriculture and Commodities Division, WTO
Geneva, 2 November 2021
1
Outline
Harmonization in the SPS Agreement
Monitoring the process of international harmonization
in the SPS Committee
Transparency and international harmonization
Q & A
International harmonization in the SPS Agreement,
an overview
Preamble
…further the use of harmonized SPS measures
between Members, on the basis of international
standards, guidelines and recommendations developed
by the relevant international organizations …
Harmonization in the SPS Agreement
Objective?
What is harmonization?
Annex A.2 – Definition
The establishment, recognition and application
of common sanitary and phytosanitary measures
by different Members
Harmonization in the SPS Agreement
Annex A.2
Standard-setting organizations
food safety plant health
animal health
and zoonoses
Codex = Joint FAO/WHO Codex Alimentarius Commission
OIE = World Organisation for Animal Health
IPPC = International Plant Protection Convention (FAO)
Harmonization in the SPS Agreement
Annex A.3
Which international standards?
Article 3.1: To harmonize SPS measures… Members
shall base their SPS measures on international
standards, guidelines and recommendations, .... except as
otherwise provided for in this Agreement, and in particular
in paragraph 3
Article 3.2: Measures that conform to
international standards shall be deemed to be
necessary to protect human, animal or plant life
or health, and presumed to be consistent with
the relevant provisions of this Agreement....
Harmonization in the SPS Agreement
Article 3
What does it say?
Alternatives to harmonization?
Article 3.3
• if there is a scientific justification
• as a consequence of an appropriate level
of protection, in conformity with Article 5
(risk assessment)
Harmonization in the SPS Agreement
Article 3
International
Standards
(Art. 3.1, 3.2)
Does a relevant
international
standard exist?
Is the measure
“based on” a
relevant
international
standard?
Does the measure
“conform to” the
international
standard?
Risk Assessment
(Art. 3.3, 5.1)
Does the measure
result in a higher
level of protection
than that achieved
by the international
standard?
Is this measure
based on a risk
assessment?
OR
Harmonization in the SPS Agreement
Article 3
How to comply?
Harmonization in the SPS Agreement
Disputes – selected take-aways
“Based on” international standards – Measure adopts some but not necessarily all elements
“Based on” – founded , built upon, supported by the relevant international standard; can
not contradict the international standard
Presumption of consistency – “conform to” ≠ “based on”
If an SPS measure incorporates all the elements of the international standard, it
“conforms to”
Right to be stricter than international standards if measure justified with risk
assessment
No particular distinction between "standards", "guidelines" and "recommendations"
Amendments to standards – latest science
Article 12.4
Article 3.5 Article 12.1
…develop a procedure to
monitor the process of
international harmonization
…coordinate efforts in this
regard with the relevant
international organization
[SPS Committee]…shall carry
out the functions necessary to
implement the provisions of this
Agreement and the furtherance
of its objectives, in particular
with respect to harmonization
Refers to 12.1 and 12.4
…develop a procedure to
monitor the process of
international harmonization and
the use of international
standards, guidelines or
recommendations
…establish a list of international
standards, guidelines or
recommendations relating to
SPS measures which the
Committee determines to have a
major trade impact
Monitoring the process of international harmonization
in the SPS Committee
 Oct. 1997 – Initially adopted by SPS Committee, provisional
 Nov. 2004 – Revised
 June 2006 - Extended indefinitely; reviewed under the
periodic review of the SPS Agreement
G/SPS/11/Rev.1 – Revision of the Procedure to
Monitor The Process of International Harmonization
Monitoring the process of international harmonization
in the SPS Committee
SPS Monitoring Procedure (G/SPS/11/Rev.1)
How does it work?
 Aim of encouraging Members to use international standards
 Identifying where there is a major impact on trade resulting from
the non-use of standards
 Help to understand when an international standard, guideline or
recommendation is needed by:
 Identifying the required international standard
 Information from Members on their use or non-use
Art.
12.4
SPS Monitoring Procedure (G/SPS/11/Rev.1)
How should it work?
12
Para. 6
Para. 4
Para. 8
A list of standards, guidelines or recommendations which have a major
impact on international trade shall be established and reviewed at each
meeting of the Committee
Members should submit concrete examples of problems with a significant trade
impact related to the use or non-use of international standards. Describe, whether
it is the result of:
(a) non-use of an existing standard; or
(b) absence or inappropriateness of existing standard
Scope of Monitoring limited to Standards, Guidelines and Recommendations
developed by Codex, OIE, IPPC (par. 4)
SPS Monitoring Procedure (G/SPS/11/Rev.1)
How should it work?
Para. 9
Para. 10
The Secretariat should prepare an annual report to the Committee
on the list of standards, the major trade impacts identified on use,
non-use, or absence of international standard. The Committee will
transmit the report to the ISSBs. Members to take this into account,
through their participation, in establishing those organizations’
work priorities.
The Committee may invite Codex, OIE, IPPC to provide further
information in writing or through presentations on any standard under
consideration, incl. with regard to any changes or ongoing revisions.
SPS Monitoring Procedure (G/SPS/11/Rev.1)
How did it work?
July 1999 – Adoption of 1st Annual Report (G/SPS/13)
Main steps:
 Members identified 9 standards-related issues (1998)
 Secretariat circulated document to gather information from
Members on issues identified (G/SPS/W/100, March 1999)
 Responses summarized in 1st Annual Report
 Communication sent to ISSBs asking for their input
Para. 6
Para. 8
Para. 10
Para. 9
Oct. 2000 – 2nd Annual Report, replies from ISSBs (G/SPS/16)
2nd Review (G/SPS/36)
 12 issues raised (1999-2004)
 Concerns raised by developing Members about ability to
actively participate in the development of international
standards
 Codex, OIE, IPPC to establish trust funds to enhance
participation
SPS Monitoring Procedure (G/SPS/11/Rev.1)
Periodic Reviews of SPS Agreement
 3rd and 4th Reviews (G/SPS/53, G/SPS/62)
 Procedure under-utilized by Members (2005-2013)
 July 2012 - Proposal to revise the monitoring procedure:
 Include in Annual Report issues raised under STCs when related to non-use or absence of
international standards
 Members should ensure full implementation of transparency provisions, including
recommendations (G/SPS/7/Rev.3, 2008)
 Indicate if conformity
 Notify all regulations even when based on / conform to
 5th Review (G/SPS/64 and Add.1, 2014-2019)
 Summary of issues (new, previous) considered and responses received from ISSBs (current
practice)
 Latest Annual Report (23rd) – G/SPS/GEN/1909, May 2021
SPS Monitoring Procedure (G/SPS/11/Rev.1)
Periodic Reviews of SPS Agreement
Codex
4%
IPPC
12%
OIE
73%
None
11%
Emergency notifications
Codex
27%
IPPC
13%
OIE
9%
None
51%
Regular notifications
Transparency and international harmonization
SPS notifications referring to an international standard
2008 – 15 Oct. 2021
Conform to
69%
Conform to
87%
Recommended Transparency Procedures (G/SPS/7/Rev.4)
Animal Health
47%
Food Safety
34%
Plant Health
14%
Other
5%
Transparency and international harmonization
STCs and international standards
1995 – 15 Oct. 2021 (Total STCs = 525)
Source: SPS Information Management System (http://spsims.wto.org)
196 STCs
With keyword
“International Standards
/ Harmonization”
37%
(196/525)
 HPAI-related restrictions on poultry products - request to follow
OIE standards, particularly on regionalization
 …harmonize MRLs with those established by Codex, in
accordance with the SPS Agreement
 …country-wide bans on imports of meat products on grounds of
ASF not based on OIE standards or on regionalization
principles
 deviation from Codex standards with regard to pesticides
Transparency and international harmonization
STCs and international standards - Examples
Thank you!
SPS Gateway
http://www.wto.org/sps

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01_wto-sps_and_harmonization.pdf

  • 1. International harmonization in the SPS Agreement, an overview Rolando Alcala Agriculture and Commodities Division, WTO Geneva, 2 November 2021
  • 2. 1 Outline Harmonization in the SPS Agreement Monitoring the process of international harmonization in the SPS Committee Transparency and international harmonization Q & A International harmonization in the SPS Agreement, an overview
  • 3. Preamble …further the use of harmonized SPS measures between Members, on the basis of international standards, guidelines and recommendations developed by the relevant international organizations … Harmonization in the SPS Agreement Objective?
  • 4. What is harmonization? Annex A.2 – Definition The establishment, recognition and application of common sanitary and phytosanitary measures by different Members Harmonization in the SPS Agreement Annex A.2
  • 5. Standard-setting organizations food safety plant health animal health and zoonoses Codex = Joint FAO/WHO Codex Alimentarius Commission OIE = World Organisation for Animal Health IPPC = International Plant Protection Convention (FAO) Harmonization in the SPS Agreement Annex A.3 Which international standards?
  • 6. Article 3.1: To harmonize SPS measures… Members shall base their SPS measures on international standards, guidelines and recommendations, .... except as otherwise provided for in this Agreement, and in particular in paragraph 3 Article 3.2: Measures that conform to international standards shall be deemed to be necessary to protect human, animal or plant life or health, and presumed to be consistent with the relevant provisions of this Agreement.... Harmonization in the SPS Agreement Article 3 What does it say?
  • 7. Alternatives to harmonization? Article 3.3 • if there is a scientific justification • as a consequence of an appropriate level of protection, in conformity with Article 5 (risk assessment) Harmonization in the SPS Agreement Article 3
  • 8. International Standards (Art. 3.1, 3.2) Does a relevant international standard exist? Is the measure “based on” a relevant international standard? Does the measure “conform to” the international standard? Risk Assessment (Art. 3.3, 5.1) Does the measure result in a higher level of protection than that achieved by the international standard? Is this measure based on a risk assessment? OR Harmonization in the SPS Agreement Article 3 How to comply?
  • 9. Harmonization in the SPS Agreement Disputes – selected take-aways “Based on” international standards – Measure adopts some but not necessarily all elements “Based on” – founded , built upon, supported by the relevant international standard; can not contradict the international standard Presumption of consistency – “conform to” ≠ “based on” If an SPS measure incorporates all the elements of the international standard, it “conforms to” Right to be stricter than international standards if measure justified with risk assessment No particular distinction between "standards", "guidelines" and "recommendations" Amendments to standards – latest science
  • 10. Article 12.4 Article 3.5 Article 12.1 …develop a procedure to monitor the process of international harmonization …coordinate efforts in this regard with the relevant international organization [SPS Committee]…shall carry out the functions necessary to implement the provisions of this Agreement and the furtherance of its objectives, in particular with respect to harmonization Refers to 12.1 and 12.4 …develop a procedure to monitor the process of international harmonization and the use of international standards, guidelines or recommendations …establish a list of international standards, guidelines or recommendations relating to SPS measures which the Committee determines to have a major trade impact Monitoring the process of international harmonization in the SPS Committee
  • 11.  Oct. 1997 – Initially adopted by SPS Committee, provisional  Nov. 2004 – Revised  June 2006 - Extended indefinitely; reviewed under the periodic review of the SPS Agreement G/SPS/11/Rev.1 – Revision of the Procedure to Monitor The Process of International Harmonization Monitoring the process of international harmonization in the SPS Committee
  • 12. SPS Monitoring Procedure (G/SPS/11/Rev.1) How does it work?  Aim of encouraging Members to use international standards  Identifying where there is a major impact on trade resulting from the non-use of standards  Help to understand when an international standard, guideline or recommendation is needed by:  Identifying the required international standard  Information from Members on their use or non-use Art. 12.4
  • 13. SPS Monitoring Procedure (G/SPS/11/Rev.1) How should it work? 12 Para. 6 Para. 4 Para. 8 A list of standards, guidelines or recommendations which have a major impact on international trade shall be established and reviewed at each meeting of the Committee Members should submit concrete examples of problems with a significant trade impact related to the use or non-use of international standards. Describe, whether it is the result of: (a) non-use of an existing standard; or (b) absence or inappropriateness of existing standard Scope of Monitoring limited to Standards, Guidelines and Recommendations developed by Codex, OIE, IPPC (par. 4)
  • 14. SPS Monitoring Procedure (G/SPS/11/Rev.1) How should it work? Para. 9 Para. 10 The Secretariat should prepare an annual report to the Committee on the list of standards, the major trade impacts identified on use, non-use, or absence of international standard. The Committee will transmit the report to the ISSBs. Members to take this into account, through their participation, in establishing those organizations’ work priorities. The Committee may invite Codex, OIE, IPPC to provide further information in writing or through presentations on any standard under consideration, incl. with regard to any changes or ongoing revisions.
  • 15. SPS Monitoring Procedure (G/SPS/11/Rev.1) How did it work? July 1999 – Adoption of 1st Annual Report (G/SPS/13) Main steps:  Members identified 9 standards-related issues (1998)  Secretariat circulated document to gather information from Members on issues identified (G/SPS/W/100, March 1999)  Responses summarized in 1st Annual Report  Communication sent to ISSBs asking for their input Para. 6 Para. 8 Para. 10 Para. 9 Oct. 2000 – 2nd Annual Report, replies from ISSBs (G/SPS/16)
  • 16. 2nd Review (G/SPS/36)  12 issues raised (1999-2004)  Concerns raised by developing Members about ability to actively participate in the development of international standards  Codex, OIE, IPPC to establish trust funds to enhance participation SPS Monitoring Procedure (G/SPS/11/Rev.1) Periodic Reviews of SPS Agreement
  • 17.  3rd and 4th Reviews (G/SPS/53, G/SPS/62)  Procedure under-utilized by Members (2005-2013)  July 2012 - Proposal to revise the monitoring procedure:  Include in Annual Report issues raised under STCs when related to non-use or absence of international standards  Members should ensure full implementation of transparency provisions, including recommendations (G/SPS/7/Rev.3, 2008)  Indicate if conformity  Notify all regulations even when based on / conform to  5th Review (G/SPS/64 and Add.1, 2014-2019)  Summary of issues (new, previous) considered and responses received from ISSBs (current practice)  Latest Annual Report (23rd) – G/SPS/GEN/1909, May 2021 SPS Monitoring Procedure (G/SPS/11/Rev.1) Periodic Reviews of SPS Agreement
  • 18. Codex 4% IPPC 12% OIE 73% None 11% Emergency notifications Codex 27% IPPC 13% OIE 9% None 51% Regular notifications Transparency and international harmonization SPS notifications referring to an international standard 2008 – 15 Oct. 2021 Conform to 69% Conform to 87% Recommended Transparency Procedures (G/SPS/7/Rev.4)
  • 19. Animal Health 47% Food Safety 34% Plant Health 14% Other 5% Transparency and international harmonization STCs and international standards 1995 – 15 Oct. 2021 (Total STCs = 525) Source: SPS Information Management System (http://spsims.wto.org) 196 STCs With keyword “International Standards / Harmonization” 37% (196/525)
  • 20.  HPAI-related restrictions on poultry products - request to follow OIE standards, particularly on regionalization  …harmonize MRLs with those established by Codex, in accordance with the SPS Agreement  …country-wide bans on imports of meat products on grounds of ASF not based on OIE standards or on regionalization principles  deviation from Codex standards with regard to pesticides Transparency and international harmonization STCs and international standards - Examples