G/SPS/W/308  
 
17 September 2018 
(18-5722) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
IMPLEMENTATION OF TH E SPS AGREEMENT – REGULATORY ISSUES  
FIFTH REVIEW  
Submission from Brazil  
The following communication, received on 14 September  2018, is being circulated at the request of 
the Delegation of Brazil . 
 
_______________  
 
 
On the occasion of  the Fifth Review of the operation and implementation of the Agreement on 
Sanitary and Phytosanitary Measures (SPS), Brazil presents to the Committee on Sanitary and 
Phytosanitary Measures the following matter for its consideration, recommendation and poss ible 
adoption.  
1  SCIENTIFIC JUSTIFICA TION (ARTICLE 2.2), ASSESSMENT OF RISK A ND 
DETERMINATION OF THE  APPROPRIATE LEVEL O F SANITARY OR PHYTOS ANITARY 
PROTECTION (ARTICLE 5) 
1.1.  The SPS Agreement has provided a solid basis for managing regulatory issues in the area  of 
trade in agricultural products, but it is important, in the context of the 5th Review of the SPS 
Agreement, to reinforce and promote its main features in order to reaffirm its objectives and goals. 
Since the last review of the Agreement, the connection  between SPS regulation and science has 
been one of the main topics of discussion in the SPS Committee , as well as i n other WTO fora.  
1.2.  Article 2.2 of the SPS Agreement establishes that science -based approaches and scientific 
evidence must be the foundation of SPS measures adopted and applied by Members. This principle 
has been of paramount importance to the proper functioning of the multilateral trading system and 
to the overcoming of non -tariff barriers to trade.  
1.3.  Furthermore, Article 5 of the SPS Agreement requires Members to base their me asures on  risk 
assessment, understood as the most accepted scientifically based process to determine sanitary and 
phytosanitary requirements. According to the Codex Alimentarius Procedural Manual, the process of 
risk assess ment consists of : (i) hazard identification ; (ii) hazard characterization ; (iii) exposure 
assessment;  and (iv) risk characterization.  
1.4.  The link between these two pillars of the SPS Agreement – science -based approach and risk 
analysis - has been recognized by the Dispute Settlement Body in a number of cases (EC -Hormones, 
US/Canada -Continued Suspension, EC -Biotech, Australia -Salmon, US -Poultry). Many WTO Members 
have currently stressed and defended this link, as demonstrated through the increasing number of 
specific trade concerns raised by Members on the SPS Committee, as well as dispute complaints, 
related to SPS measures that are not base d on international standards, guidelines and 
recommendations or that may be based on inadequate scientific justification 
(G/SPS/GEN/1143/Rev.2).  
1.5.  In a regulatory context, adopting an appropriate set of criteria for the determination of hazard, 
exposure and risks is important for regulating trade in agricultural products, with a view to minimize G/SPS/W/308  
 
- 2 - 
 
  possible adverse impacts of SPS regulation on international trade in food and agricultural products, 
while safeguarding human, animal and plant health.  
1.6.  In the case w here relevant scientific evidence is insufficient, Brazil understands that the 
possibility highlighted under Article 5.7 sho uld neither be used to maintain  measures that are more 
restrictive than necessary to protect human, animal or plant life or health, nor to dismiss Members 
of their obligation to seek the information necessary for a more objective assessment of risk.  
1.7.  Many WTO Members have recently indicated concerns regarding the use of methodologies and 
provisional measures with a view to restrict trad e, in spite of the obligations referred to in Article s 5.4 
and 5.6 of the SPS Agreement. International standards, guidelines and recommendations to 
streamline and harmonize procedures for the adoption of provisional measures or other measures, 
in the case of insufficient scientific evidence, can also be object of the work of the relevant 
international organizations recognized by t he SPS Agreement.  
1.8.  One of the functions of these organizations is to provide a technical and independent forum for 
advancing trans parency and predictability for methodological procedures associated with the 
application and development of SPS measures. Governments drafting and applying SPS measures 
should refer to these organizations also to help avoiding disagreement over SPS issues.  The SPS 
Committee, taking into consideration its objective of securing the best available scientific and 
technical advice for the administration of this Agreement, can work with relevant organizations to 
foster technical expertise regarding the specific i ssue of Article 5.7, particularly in addressing the 
necessary steps for the establishment of a measure.  
1.9.  Overall, the possibility of a WTO Member adopting provisional measures for their respective 
level of protection when the body of available scientific ev idence is not appropriate in order to carry 
out a risk analysis according to the Codex Alimentarius Procedural Manual is a key principle of WTO 
law. Nevertheless, regulation in this context should be notified with a reference to Article 5.7 and 
Members sho uld be urged to continue searching and seeking for scientific evidence that would make 
it possible to perform an objective risk assessment and moving these measures away from the 
threshold of Article 5.7. Moreover, it should be noted that the scientific ev idence associated with a 
specific SPS measure can always be supplemented with additional information . 
1.10.   Not only the outcomes of adopted measures, but also the development of international 
standards and methodologies for risk analysis may improve transparenc y and predictability in 
agricultural trade as well as promote greater harmonization between WTO Members. In this sense, 
the harmonization of SPS standards regarding the topics of assessment of risks and determination 
of the appropriate level of sanitary or  phytosanitary protection may promote greater predictability 
in SPS matters and facilitate access to food and other agricultural products worldwide.  
2  PROPOSAL  
2.1.  In order to develop and promote the adoption of science -based procedures for the 
implementation of  the SPS Agreement, Brazil proposes the following:  
(a) Members should be urged to recognize that the risk assessment, as regulated under Article 
5.1, is the main criteria and means by which scientific justification is attained for the 
adoption and implementation of SPS measures.  
(b) Members should – when making notifications of corresponding provisional measures – 
specify that they are taken under Article 5.7, stating their views on the insufficiency of 
scientific evidence in relation to the issue that gave origin to the measure and that the 
Member has sought and will continuously seek additional information in order to review the 
measure accordingly and within a reasonable period of time.  
(c) The Committee should ask Codex Alimentarius, as well as other rel evant international 
organizations, to work on the procedural steps necessary, given the impossibility of 
establishing a proper risk assessment, for the adoption and application of provisional 
measures.  
__________