G/SPS/GEN/1707  
28 June 2019 
(19-4346) Page: 1/3 
Committee on Sanitary and Phytosanitary Measures  Original:  Spanish  
 
  
EUROPEAN UNION AMENDMENTS OF MRLS FOR IMAZALIL  
(G/SPS/N/EU/319) – CONCERNS OF  
COLOMBIA AND ECUADOR  
COMMUNICATION FROM COLOMBIA AND ECUADOR  
The following communication, received on 2 7 June 2019, is being circulated at the request of the 
delegations of Colombia  and Ecuador . 
 
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The Republics of Colombia and Ecuador would like to express our concern with respect 
to the draft Commission Regulation amending Annexes II and I II to Regulation (EC) 
No. 396/2005 of the European Parliament and of the Council as regards maximum residue 
levels for imazalil in or on certain products.  
1.  By means of this specific trade concern, we wish to make the European Commission and WTO 
Members awar e of an issue that we believe to be of the utmost importance for global agricultural 
production and, particularly, for agricultural production in developing countries such as Colombia 
and Ecuador . We are grateful for the consideration given to our views on  this issue, which are aimed 
at promoting the agricultural development of banana producing countries worldwide.  
2.  The WTO Agreement on the Application of Sanitary and Phytosanitary Measures provides that 
Members shall ensure that measures are not more trade -restrictive than required to achieve their 
appropriate level of protection, taking into account technical and economic feasibility . The 
above -mentioned European Union regulation, however, reduces the maximum residue levels (MRLs) 
for imazalil in bananas fr om 2.0 to 0.01 mg/ kg. This would, in practice, make its use unfeasible 
despite its recent evaluation and approval at European level barely five years ago.  
3.  Imazalil is a fungicide used by banana producing countries as a key post -harvest tool for 
preserving product quality and safety and keeping the product free from mould and fungus during 
storage and transport and the period when it is available for sale before reaching consumers on the 
European market . We see that there are currently no phytosanitary alter natives available on the 
market that can be used in bananas (nor are there other alternatives comparable in quality and 
efficacy) . The loss of this tool for preserving crops would make it unfeasible for producers to be able 
to respond to market demand.  
4.  It follows from the foregoing that the draft regulation must take into account the scientific 
evidence generated from studies in experimental animals as well as epidemiological studies on 
exposed populations to clearly establish disruption as an effect , there by eliminat ing the presumption 
of adverse effects.  
5.  In Colombia, 50,000 hectares are dedicated to the production of  bananas for the European 
market, and the marketing and distribution of those bananas in the European Union could be affected 
by this measure . They produced a  total of 1,700,000 tonnes in 2016, which accounted for 90 % of 
total domestic banana production.  
6.  Colombia's banana exports to the European Union account for 80 % of all its agricultural exports 
to that market . They amounted to USD 665  million  in 2018 and benefited remote areas of the G/SPS/GEN/1707  
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  country where the armed conflict had taken place . The main destinations are Germany, Belgium, 
Spain and the Netherlands.  
7.  Ecuador is the world's leading banana exporter, with trade with around 87 markets 
internationally, including the European Union . Bananas are Ecuador's main export to that bloc, 
representing 30 % of the total exported . In Ecuador, banana exports account for 2 % of overall GDP 
and around 35 % of agricultural GDP . Banana production in Ecuador f alls mainly in the realm of the 
household  economy and the "popular and solidarity economy ", which means the sector contributes 
to job creation and poverty reduction.  
8.  A review of the Codex Alimentarius reveals an MRL of 2.0 mg/kg for imazalil in bananas . The 
European Union's amendment of the MRL for imazalil deviates unjustifiably from the Codex 
Alimentarius standard and lacks any scientific basis.  
9.  We believe that any measure applied by the European Union must be prepared in accordance 
with the WTO SPS Agree ment, particularly Article 2.2 (the SPS measure shall be based on scientific 
principles), Article 5.2 (in the assessment of risks, Members shall take into account available 
scientific evidence, relevant processes and production methods, and relevant inspec tion, sampling 
and testing methods) and Article 5.3 (Members shall take into account as relevant economic factors 
the potential damage in terms of loss of production or sales).  
10.  In light of  the foregoing, it is clear that the "default" MRL of 0.01 mg/kg set for imazalil in 
bananas lacks a technical or scientific basis and creates a restriction on access to the European 
Union, which will have a significant economic and social impact on banana  producing countries.  
11.  It should be noted that, in 2010, the EFSA (European Food Safety Authority) published a report 
containing the conclusions of the risk assessment of the active substance imazalil (EFSA, 2010) . 
From the mutagenicity studies presented, i t was concluded that imazalil was not genotoxic . In 
evaluating other effects, it was concluded that imazalil was neither a reproductive toxicant nor a 
teratogen.  
12.  The European Union's reasons for proposing this amendment are not based on the identification 
of a risk to consumers, but rather on the lack of the necessary studies that would allow certain risks 
to be dismissed . Those studies could not be conducted beforehand by the producer of the substance, 
but the EFSA indicated that it needed them in order to  be able to to conclude its scientific evaluation . 
Consequently, the EFSA's two Scientific Opinions on MRLs for imazalil do not propose a specific MRL 
and indicate that more studies need to be done before a decision can be reached . However, the 
Commission has interpreted the lack of a conclusion by the EFSA as a health risk.  
13.  We understand that the Netherlands, the evaluating member State, authorized the initiation of 
the necessary vertebrate studies identified by the EFSA . Those studies are expected to be a vailable 
in the first quarter of 2020, at which time they will be evaluated by the Netherlands and then sent 
to the EFSA.  
14.  We are quite concerned about the proposal to change the MRL for imazalil in bananas from 2.0 
to 0.01 mg/kg , as r isk analysis had not b een taken into account as a methodological tool in the 
decision -making process ; according to the EFSA's review, there was insufficient scientific evidence 
of genotoxicity for three metabolites of imazalil (R014821, FK -772 and FK -284) although  negative 
results from in vitro  tests were reported in a n FAO/WHO document.  
15.  According to the calculations and under the scenarios contemplated for acute and chronic 
intakes in the two diets evaluated for citrus fruits and bananas , in conservative scenarios, no health 
risk was found, indicating that the existing MRLs are safe.  
16.  Changing the value of the MRL to the limit of quantification of residues according to the 
analytical technique, when those values are determined on the basis of supervised trials and require 
validat ion of toxicological safety, would make it irrelevant  given the absence of information.  
17.  This decision would run counter to the most recent work done, in 2018, on Codex MRLS, which 
included MRL values well above the limit of quantification . The WHO/FAO JMPR (Joint Meeting on 
Pesticide Residues) evaluated the same group of studies on imazalil as the Netherlands and the EFSA G/SPS/GEN/1707  
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  and found that there was no type of risk to consumers and recommended new MRLs for the 
substance even higher than those cu rrently agreed under Codex . The JMPR is the leading 
international body of experts for the evaluation of pesticides and residues and constitutes the 
scientific arm for risk management.  
18.  It should also be noted that the European Union's comments regarding the  effects in bananas 
were considered at the last meeting of the Codex Committee on Pesticide Residues, which took place 
in April 2019. Nevertheless, that Committee recognized the 2018 JMPR report and seemed 
favourable to increasing MRLs for bananas from 2.0  to 3.0 mg/kg.  
19.  With respect to the European Union's argument regarding an excess in the acute reference dose 
(ARfD) for bananas, we kindly request that the European Union consider the new scientific evidence 
from Spain, as that would resolve the issue.  
20.  The initial studies on bananas were conducted on samples treated with a 600 ppm dose of 
imazalil (the dose used in Latin America, not 300 -375 ppm, the dose used in the European Union), 
which presented a risk to consumers, on the basis of EFSA models, because the ARfD was exceeded . 
Recently, however, studies conducted in Spain using a 300 ppm dose have come to light . Those 
studies would show that the ARfD is not exceeded with this dose, which would allow the 
Directorate -General for Health and Food Safety to set  safe MRLs for European consumers.  
21.  We believe that the amendment of the MRL for imazalil in bananas to 0.01 mg/kg lacks a 
scientific basis and deviates unjustifiably from the international reference set in the 
Codex  Alimentarius (2.0 mg/kg) . We therefore c all on the European Union to maintain the current 
MRL of  2 mg/kg for the imazalil molecule in bananas, as set in the Codex Alimentarius, until the 
European Union develops and evaluates new studies . We ask that the MRL only be applied through 
a scientific a ssessment of the risk, as set forth in the WTO SPS Agreement, providing real health 
protection and not constituting a disguised barrier to trade.  
22.  This request is grounded in the WTO SPS Agreement, which provides that, in determining the 
appropriate level o f sanitary or phytosanitary protection, Members should minimize negative trade 
effects and that sanitary and phytosanitary measures should be scientifically and technically 
justified, be based on risk assessment and not constitute unjustified barriers to t rade. 
23.  We are very concerned that the European Union's regulatory amendments regarding MRLs do 
not have adequate technical or scientific support a nd are based on hazard, not risk . We therefore 
highlight  the need to use "risk analysis" as a methodological to ol for making decisions on pesticide 
use, under its three components of assessment, management and communication, in order to  
protect public health and the environment, and as a tool for facilitating international trade in 
agricultural products . A review o f the European Union's proposal shows that risk assessment is losing 
ground , with the decision to accept or allow the use of substances being made under a hazard based 
approach  and the conditions of use that can define risk scenarios and lead to  scientific ally based 
decisions  being neglected . 
24.  To conclude, we would also like to express our deep concern regarding the "transition periods" 
granted by the European Union for provisions amending maximum residue limits (MRLs) . It should 
be noted that in view of har vesting periods and the times when agrochemicals are applied, the six 
month period prior to the implementation of the provision, as provided for in the SPS Agreement, 
does not give enough time to make the necessary adjustments to production so as to ensure  that 
agricultural products comply with the new MRLs . For processed and/or frozen products, the situation 
can be even more problematic.  
25.  Transition periods should be examined in a light that differs from the general rule of a reasonable 
interval of six mont hs under Annex B.2 of the SPS Agreement (Ministerial Decision WT/MIN(01)/17), 
as farmers need more time to adapt to MRL requirements, since it takes 36 months on average to 
develop a new phytosanitary pest control product . Colombia notes, in this regard, t hat Article 10.2 
of the SPS Agreement provides for the granting of longer time frames for compliance with sanitary 
and phytosanitary measures for products of interest to developing country Members, with a view to 
maintaining opportunities for their exports . 
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